This blog recaps a section of our recent webinar, to watch the entire presentation, visit Techniques to Manage Work Breakdown Structures.

Streamline Your Program Management: Techniques to Manage Work Breakdown Structures (WBS)

In aerospace and defense program management, success hinges on coordinating complex, interconnected projects while maintaining clear visibility across your entire program. When managing multiple systems and stakeholders, your work breakdown structure becomes the foundation that either strengthens or undermines your project’s success.

In this webinar, Cary Bryczek, Director of Aerospace & Defense Solutions at Jama Software, demonstrates how to incorporate MIL-STD-881F work breakdown structures into Jama Connect^® as part of your systems engineering processes.

Whether you’re managing space systems, information systems, or strategic missile programs, this webinar will show you how to streamline your program management with techniques to manage your WBS.

Key Takeaways:

• MIL-STD-881F fundamentals: Understanding the Department of Defense Standard Practice and how it improves acquisition communication
• Real-world implementation: See how MIL-STD-881F work breakdown structures can be incorporated into Jama Connect, including a live demonstration.
• Cross-functional alignment: Strategies to coordinate teams and manage interdependencies across complex defense programs
• Commodity-specific insights: How WBS elements apply to space systems, information systems, launch systems, and strategic missile systems
• Communication enhancement: Best practices for developing uniform WBS processes that improve stakeholder alignment and regulatory compliance.

Webinar Preview, Click HERE to Watch The Entire Presentation

TRANSCRIPT PREVIEW

Cary Bryczek: So, here’s a quick look at what we will cover today, and in the end we’ll have a Q&A of course. So, we’ll talk about some strategies for a work breakdown structure construction, obviously we’ll talk about what WBS is used for, we’ll look at a WBS hierarchy, and the product breakdown structure, talk about the differences, we’ll see a live example in Jama Connect, and we’ll finish up with maybe some possible extensions that you might use in Jama Connect through integration. So, what is a work breakdown structure? I went out there and did some research. Project management institute talks about a work breakdown structure being, that it defines a deliverable-oriented hierarchical decomposition of the work to be executed by the project team to accomplish the objectives.

Really, when you see these kinds of definitions, the important parts are the deliverable-oriented and the work. So, it’s not like a task list, it’s what you’re doing to produce the product or the system that you’re building. The Defense Acquisition University defines a WBS as a product-oriented family tree of hardware, software, services, data, and facilities. So, the theme really is this product-oriented and a tree composition of the work breakdown structures. And it’s not only composed of the product pieces itself, but the services and the data and the facilities and the results of the systems engineering efforts. So, it’s the effort plus the product itself. Who uses work breakdown structures? Really, they’re required or strongly recommended in various industries and government sectors, especially where project management, cost control, and systems engineering are critical.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Aerospace

Bryczek: With aerospace and defense contractors, they are required to submit a WBS as part of their proposals and their contracts. They are used for cost estimation, scheduling, and risk management. Construction and engineering firms, WBS is essential for managing large infrastructure projects. It’s often required by clients or even regulatory bodies. IT software development, project management professionals, so there’s a lot of people that are project management professionals that are using a WBS as part of their repertoire to deliver good projects, or even consult with organizations to deliver good project management practices.

WBS has lots of standards and guidelines to assist practitioners. So, in many cases, following the specific guidance within the documents is mandatory. Here I’ve just highlighted some notable guidelines, MIL-STD-881 is required for all ACAT programs, NASA also has a very prescriptive method to implement WBS, PMI has published books, and has lots of references available online for practitioners. The European, I didn’t capture this one, but the European Cooperation for Space Standardization, the ECSS group, in Europe, they provide detailed guidance as well on work breakdown structures through their management standards. And they reference principles from ISO 9000, and it really aligns their standards and their product assurance through a harmonized way to do work breakdown structures.

So, what’s the purpose of a WBS? It’s an assistant mechanism for any stakeholder really, in the development of a clear vision of the end products, or the outcomes to be produced by the product. So, it’s a framework for all of the deliverables throughout the life cycle. So, the WBS extends the product breakdown structure because it’s capturing all of the work that’s necessary for the project by adding in the non-product work. So, if you’re constructing a bicycle, well, I have to draft the CAD model, I have to review it, I have to do a lot of these things that are not necessarily part of the bicycle, a component, but these are part of the engineering activities. So, a work breakdown structure is not a to-do list, it’s not a schedule or an estimate, and it’s not really a tool to even make your life harder.

RELATED: Cybersecurity in the Air: Addressing Modern Threats with DO-326A

Bryczek: So, it supports very large projects so that you can eliminate risk, and also it will help you with the scope creep as well. So, you don’t want to do more work than what’s on that WBS, so it really helps people understand the scope of the kinds of activities that they’re producing because it is deliverable based. So, the benefits, it helps prevent work from slipping through the cracks, it helps people understand where the pieces fit into the overall project management plan. So, if you’re a software developer and you’re writing this one piece of the software requirement spec, or the software system spec, now you know why your deliverable is due, when, and how it fits in with the overall structure. It facilitates that communication and cooperation across the whole team, it also helps you prevent changes, that WBS is kind of like, this is the guide path for everything that you do. And it helps get team buy-in and helps build the team. it helps people get their mind around the project itself.

So, what do we have to do to create the statement of the work breakdown structure? So, a work breakdown structure is, first, you go through this process of identifying the system or the project end item to be structured. So, you’re trying to understand that scope, what is it that we’re building? And then, you take that product and you successively subdivide it into increasingly detailed and manageable subsidiary work products or elements. So, you’re taking this product, this bicycle, and you’re decomposing it. I have a frame, I have the front wheel, I have the rear wheel, I have the brakes… And then, what you’re going to do is take that product breakdown structure that’s been subdivided, and now use that to determine what the work breakdown structure is. So, you’re going to focus on these outcomes and identify these deliverables. So, the focus is supposed to be on the outcomes, not the activities needed to reach them.

TO WATCH THE ENTIRE WEBINAR, VISIT:
Techniques to Manage Work Breakdown Structures

In this blog, we recap a preview of our recent webinar. Click HERE to watch it in its entirety.

Making Sense of ASQMS: A New Standard for Automotive Software Quality

The Next Automotive Software Standard Is Here. Are You Ready for ASQMS?

The shift toward software-defined, new energy, and intelligent vehicles is transforming the automotive industry. As vehicles become more reliant on complex software to power advanced features, autonomy, and connectivity, the need for robust quality management has never been greater. To meet this challenge, China’s CACPQSP introduced the Automotive Software Quality Management System (ASQMS).

In this blog, we recap a preview of our recent webinar in which hosts Sathihya Ramamoorthy (Jama Software) and Ronald Melster (Melster Consulting GmbH) discuss how ASQMS fits into the standards landscape and why it matters for your teams.

What You’ll Learn:

• An overview of ASQMS, who published it, and why it matters
• Key differences between ASQMS, ASPICE, and IATF, including new lifecycle requirements
• Why ASQMS complements, rather than replaces, ASPICE
• Practical tips for risk-based software classification and lifecycle coverage
• Actionable next steps to strengthen software quality and efficiency

The Above Video Is A Preview – Click HERE To Watch The Entire Webinar

VIDEO TRANSCRIPT PREVIEW

Ronald Melster: Thank you very much for the warm introduction and thank you very much also for inviting me to today’s webinar. I am excited to be here with all of you and to share with you the information about this new standard ASQMS. So let’s get started and explore what the standard means for the automotive world and how we can best adapt to it. For those of you who don’t know me yet, my name is Ronald Melster. In the automotive world, I’m simply known as Ron. As one of Europe’s most experienced Automotive SPICE principal assessors, I have spent nearly three decades helping organizations transform their development processes. Since 2005, I’ve been guiding teams not just to achieve higher capability levels, but to truly understand the why behind effective processes. My journey began in the 1990s when I studied computer science in Berlin and Edinburgh, but I quickly discovered my passion for software engineering and processes. What started as a love for coding evolved into a mission to help teams balance structure with pragmatism.

Over the years, I have had the privilege of working with industry leaders like Bosch, Audi, Porsche, and Here Technologies. One of my biggest achievements was leading a Bosch development division with 7,000 engineers worldwide to capability level 3, proving that even larger teams can embrace systematic improvements. But here’s what I’ve learned. Assessments are not just about ratings. They’re about empowering people, building confidence, and creating sustainable change. Whether it’s functional safety according to ISO 26262, cybersecurity, or process improvement initiatives, I’m here as your mentor, coach, and sparring partner. Maybe you have heard the rumors about this new China standard and you want to learn more about it. You have come to the right place. Let’s start with the name of ASQMS, Automotive Software Quality Management System. That’s the full name of the standard, and yes, it’s a Chinese standard.

We will take that apart piece by piece in this webinar. So the first question is which body exactly published this ASQMS standard? And the answer is the Chinese Association of Consumer Products Quality and Safety Promotion, short CACPQSP. Say this three times. This body is dedicated to consumer rights and their safety and regulates consumer products, including cars. To promote this, they created the ASQMS standard and demand that each OEM selling cars in China needs to be certified according to the standard. So naturally, it applies to Chinese OEMs selling in China, and it also applies to European OEMs wanting to sell cars in China as well. And there’s more. The OEMs are required to request the certificate from their suppliers as well, so it also applies to any supplier tier two or tier one if they want to be part of the supply chain for cars sold in China.

Let’s have a look at why they created the standard and why we need another standard if we have Automotive SPICE or ASPICE. The reason for that is the dependency on software in the car. The complexity is growing rapidly. The number of technical and organizational interfaces gets bigger every day, and the cars increasingly rely on data coming from the outside. Let me share an observation with companies trying to reach capability level 2, according to Automotive SPICE. At the beginning of the project, the capability level is at a stable level 0. Then it takes one, or two, or even three years to get to level 1 and then to level 2. Then the project delivers the result and is finished. And the next project start again at level 0. I call this cycle the chainsaw or zigzag, up and down and up and down. It’s a huge waste of time and effort, and might have led to the ASPICE frustration, which we observed in networks like LinkedIn.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Automotive

Melster: Why is that? Because the knowledge is not captured after the project in the company, nor is it standardized or rolled out. Only few companies have managed to establish a stable level 3 with a standard process according to ASPICE. Why can a project not start in a systematic way, aka level 2 or level 3, from the start of the project? This will also reduce the technical debt, which is built up every time a project starts from level 0. There are some of the reasons why this new standard was developed. We need a strong focus on software development. We need to include the software outside the vehicle, and we need to focus on the organization to provide standard process which is applied in each and every project in a similar way. And I might add that we need to take care of the software long after the initial development phase. In a world with rising cybersecurity issues, the software must be maintained and updated if new threats become known. Therefore, ASQMS includes the entire life cycle, including the termination of the software with a systematic deletion of all personal data.

Let’s talk about what’s inside the standard ASQMS and how it’s structured. The standard contains three kinds of requirements, which must be implemented by a company which wants to be certified according to ASQMS. The first one are basic practices, not base practices, but basic practices. They’re mandatory for all automotive development. The second kind of practices are advanced practices. They must be implemented by products which are safety or cybersecurity relevant. And the third type of requirements are recommended practices. They should be implemented by all software projects. The ASQMS standard follows a risk-based approach, which means that not all requirements, which are defined by the standard need to be implemented in each development program. For that, a classification is introduced, the two classes or types of software.

Type II is a software that carries a risk related to safety or cybersecurity, and type I is the rest of the software, which is not related to safety or cybersecurity. For type II software, the cybersecurity or safety-related, the basic practices are mandatory, and the advanced practices are mandatory. The recommended practices are recommended. For type I software, which are not as critical, only the basic practices are mandatory, and advanced and recommended practices are optional. ASQMS clusters the processes into three groups: operational processes, supporting processes, and system management processes. The operational processes include project management and the entire V-model with requirements engineering, architectural design, detailed design and implementation, unit verification, integration, and verification testing.

Apart from these well-known engineering processes, the following processes are defined as part of the operational processes: supplier management, software release, software deployment, software maintenance, user information management, and software termination. So there’s some overlap and some new processes. The supporting processes include some which we already know from Automotive SPICE like configuration management, problem resolution management, change request management, and of course, quality assurance. They even have the same process names. The basic practices may differ in some aspects. And some new supporting processes are introduced like documentation management, equipment and facilities, knowledge management, revenue management, and externally supplied products and services, which includes the management of free and open-source software.

RELATED: Jama Connect^® for Automotive

Melster: With the system management processes, something completely new is introduced. They’re not to be confused with the system development processes, which we know from ASPICE. System here refers to the quality management system in the name of ASQMS. So it’s similar to ISO 9001, or ITF 16949, or an information security management system, which gets certified by TSACS. These processes include the scope and the context of the organization, the quality management system fundamentals like quality policies and roles, personnel management, performance evaluation, and the continuous improvement process. In this next section, I will highlight some of the key changes when we compare Automotive SPICE with ASQMS. The first one is the software, which is in the scope of the standard ASQMS. The requirements are not only mandatory for in-vehicle software, which many of us have known for a long time, but also for software outside the vehicle is in scope.

This includes any software in the cloud providing data to the vehicle or to an entire fleet. It furthermore includes any system along the roads, so-called roadside systems. Again, exchanging information with the car or even controlling the behavior of the vehicle. And it applies to the software tool chains which are used for software development and maintenance. The next important change is the lifecycle. Automotive SPICE development projects typically stop with the release of the finished software, whatever this means. The maintenance phase is usually left out or ignored, and really no one thinks about the termination of the software in an ASPICE project. This will change with ASQMS. The entire lifecycle of the software must be covered. This only starts with the initial development phase and must be continued with the ongoing maintenance of the software until the termination of the software. You might want to know, what is the termination more than switching off the software? Well, many software instances store data, oftentimes personal data, and this information must be securely deleted as part of the termination.

Many companies claim that they are ASPICE level 2 certified. However, this is not true. There is no such certification. What they have reached in most cases is a level 2 in one project at a certain time. So this does not apply to any other project in the same company without performing additional assessments, nor is the claim true in the future or after the assessment for the same project. So here’s the last key change I will talk about. ASPICE assessments are statements about projects at a certain point in time. This statement cannot be carried over to any other project in the company, nor is it valid in the future. ASQMS, on the other hand, focuses on the organization. This means that the organization must establish processes to fulfill the requirements and maintain them in each and every development project. This also includes internal auditing activities to make sure that all projects follow the defined rules and methods. And as I’ve mentioned earlier, it also includes processes to provide competence staff to the project. Only then will the company get the ASQMS certificate, which is published by an external auditor.

So what have we learned today about how ASPICE and ASQMS can work together? First, ASPICE integration. ASQMS will not replace Automotive SPICE. Instead, ASPICE can be used to show the conformance with the overall standard processes. And if you are already using ASPICE at the project level, these methods can be scaled to the entire organization using the approach of ASQMS. Second, both standards have shared goals. They’re built on the same fundamental principles, traceability, clear structure, and well-defined roles. Whether you’re working on a senior development project or managing quality across multiple teams, these core elements remain the same. And finally, ASQMS is extending the scope. Here’s where ASQMS goes beyond traditional ASPICE scopes. It adds organizational elements like leadership development, culture building, and personnel focus. The reality, ASPICE and ASQMS work as a partner, not competitors. Automotive SPICE gives you project-level excellence while ASQMS builds the organizational capability to sustain that excellence across all your software activities. Together, they create a comprehensive quality approach that works at every level.

This Has Been A Preview of Our Webinar, To Watch the Full Webinar, Visit:
Making Sense of ASQMS: A New Standard for Automotive Software Quality

AI in MedTech: Transforming Device Innovation and Quality

No matter where you turn these days, it is nearly impossible to escape the influence of AI. The MedTech industry is no different and stands at the brink of an AI revolution. From smarter devices to streamlined quality systems and even regulatory reviews, AI is poised to become a powerful tool across the product lifecycle.

Despite the potential, MedTech companies are lagging a little behind other industries when it comes to the use of AI. Recent industry surveys reveal that while 51% of high-tech companies have successfully integrated AI into their operations, only 24% of medical device organizations have achieved similar adoption rates. This gap represents an unprecedented opportunity for forward-thinking MedTech companies to gain competitive advantage through responsible, intelligent use of AI.

The FDA’s recent appointment of Jeremy Walsh as Chief AI Officer signals a clear regulatory shift toward embracing AI technologies that can accelerate device development while maintaining rigorous safety standards. Organizations that strategically implement AI across their device development, quality management systems, and regulatory processes will be positioned to deliver safer products faster while reducing operational costs.

AI-Enabled Medical Devices: The Next Generation

AI is increasingly embedded directly into medical devices, enabling real-time diagnostics, predictive analytics, and enhanced imaging. In fact, the FDA authorized 235 AI-enabled devices in 2024 alone, the most in its history.

Despite the success of an increasing number of devices being launched, much still needs to be done to ensure the devices are safe and meet their intended purposes.

The Validation Imperative

Recent research published in JAMA Health Forum analyzed 950 AI-enabled medical devices and found a concerning trend; devices without proper clinical validation were significantly more likely to be recalled. The study revealed that 43% of all recalls occurred within one year of FDA authorization, with diagnostic errors and functionality delays being the most common causes.

This data highlights a critical responsibility for manufacturers; robust clinical validation must be built into your AI device development process from day one. Companies that prioritize validation studies demonstrate measurably better post-market performance and reduced recall risk.

Practical Implementation Strategies for AI-enabled Devices

• Start with Data Quality: AI algorithms require clean, structured datasets to function effectively. Implement data governance protocols that ensure your training data meets the highest quality standards.
• Design for Continuous Learning: Modern AI-enabled devices benefit from continuous monitoring and improvement. Build infrastructure that supports ongoing data collection and algorithm refinement while maintaining regulatory compliance.
• Plan for Regulatory Pathways: The FDA’s 510(k) process for AI devices is evolving rapidly. Stay informed about emerging guidance documents and consider engaging with FDA early in your development process through pre-submission meetings.
• Implement Robust Testing: Beyond clinical validation, establish comprehensive testing protocols that evaluate your AI systems under real-world conditions, including edge cases and unexpected inputs.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

AI in Quality Management Systems: Efficiency Through Intelligence

AI is not just for use within a device; it can transform operations too. From document generation to requirements management to supplier evaluation, AI can dramatically reduce manual effort and improve accuracy. Yet, only 10% of Medtech companies report measurable value from AI so far, compared to 24% across other industries. Quality management represents one of the most promising applications for AI in MedTech, where document-intensive processes create natural opportunities for automation and optimization.

Document Intelligence and Process Automation

AI-powered quality management systems can transform time-consuming manual processes into streamlined, automated workflows. Leading organizations report 60-70% reductions in initial document drafting time and weeks of improvement in overall review cycles when implementing AI solutions for regulatory document generation.

The key to success lies in establishing proper document management infrastructure before deploying AI tools. When quality teams maintain organized, structured document systems, AI can effectively analyze historical deviation reports to identify emerging patterns, generate compliance documentation that aligns with current specifications, and automate routine quality review processes.

Strategic Implementation Approach

• Assess Your Document Infrastructure: Evaluate whether your team can rapidly locate current versions of critical documents and whether workflows are standardized across departments. These capabilities directly determine AI implementation success.
• Start with High-Volume, Low-Risk Processes: Begin AI implementation with routine documentation tasks like generating standard operating procedures or compiling reports. This approach allows teams to build confidence while minimizing regulatory risk.
• Maintain Human Oversight: Position AI as a capability enhancement rather than human replacement. Quality professionals should conduct comprehensive reviews and maintain final approval authority for all AI-generated content.
• Establish Clear Governance: Create company-wide guidelines that specify which quality processes can utilize AI assistance, and which require traditional human-driven approaches. This clarity ensures regulatory compliance while capturing efficiency gains.

Regulatory Bodies Embrace AI: The FDA’s Digital Transformation

The regulatory landscape is rapidly evolving to accommodate AI technologies. In a major shift, the FDA announced it will use AI to assist with scientific reviews across all centers by mid-2025. Following a successful pilot, the agency is deploying generative AI tools to reduce review times and eliminate repetitive tasks.

What This Means for MedTech Companies

The FDA’s AI implementation aims to reduce non-productive busywork and accelerate review times for new therapies and devices. This regulatory modernization creates opportunities for companies that align their submission strategies with the FDA’s digital capabilities.

• Prepare for AI-Assisted Reviews: Structure your regulatory submissions to work effectively with AI-powered analysis tools. This includes using standardized formats, clear section headings, and consistent terminology throughout your documentation.
• Leverage Data-Driven Insights: The FDA’s AI systems will likely identify patterns across submissions that can inform your development strategy. Companies that maintain robust data collection and analysis capabilities will be better positioned to benefit from these insights.
• Stay Informed on Evolving Guidance: The FDA has indicated that more details on their AI initiative will continue to be released. Monitor these developments closely and consider how they might impact your regulatory strategy.

Building Regulatory-Ready AI Systems

When developing AI-enabled devices, design your systems to generate the comprehensive documentation that regulatory bodies require. This includes maintaining detailed training data records, algorithm performance metrics, and clinical validation evidence that demonstrates real-world effectiveness.

How Jama Connect^® Can Accelerate Your AI Journey

Requirements management plays a critical role in successful AI implementation for MedTech companies. Jama Connect provides the structured foundation necessary for AI-enabled development processes.

Jama Connect Advisor™ leverages natural language processing to help teams author requirements quickly and accurately, ensuring that AI system specifications meet the highest quality standards from the outset. This AI-powered feature analyzes requirements against industry best practices such as INCOSE and EARS, providing immediate feedback that improves requirement quality and reduces development risks.

The platform’s comprehensive Live Traceability™ capabilities ensure that AI system requirements remain connected to design decisions, test results, and regulatory submissions throughout the development lifecycle. This end-to-end visibility is essential for demonstrating compliance and supporting regulatory submissions for AI-enabled devices.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Your Next Steps Forward

The intersection of AI and MedTech presents unprecedented opportunities for organizations willing to invest in the proper foundation and strategic approach. Companies that begin building their AI capabilities now will be positioned to lead the industry as regulatory frameworks mature and competitive pressures intensify.

The key to success lies not just in adopting AI technology, but in implementing it thoughtfully within robust quality management and regulatory compliance frameworks. Organizations that prioritize data quality, maintain human oversight, and align their AI strategies with evolving regulatory expectations will realize the greatest benefits from this transformational technology.

Ready to explore how AI can enhance your MedTech development processes? Book a demo with Jama Software to discover how our AI-powered requirements management solutions can help you build safer, more effective medical devices while streamlining your path to market.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish.

A Quality Leader’s Guide: How to Improve Quality Metrics in Medical Device Development

As a Quality leader in the medical device industry, you face constant pressure to not only ensure products are safe and effective, but to make sure your team is staying compliant with all applicable regulations. Passing audits, hitting project deadlines, and achieving first-time regulatory approval are always at the top of your mind. However, these important goals are often undermined by inefficient processes, disjointed systems that hinder collaboration, and teams not following your quality system procedures. The result? Delays, compliance risks, and, at the very worst, potential product issues.

This article provides a practical guide on how to overcome these challenges. We’ll explore how a modern, collaborative solution can help you improve key quality metrics, foster a true culture of quality, and turn compliance from a burden into a competitive advantage.

TL;DR: Discover how to improve your organization’s quality metrics by implementing a single source of truth for requirements, risk, and test management. With Jama Connect^®, you can leverage live traceability, out-of-the-box workflows that are compliant to medical device regulations, and powerful reuse capabilities to reduce risk and streamline product development.

The Challenge: Why Traditional Quality Management Falls Short

If your teams are still relying on a mix of documents, spreadsheets, and siloed tools, you’re likely all too familiar with the pain points. Disconnected systems make it very difficult to maintain a clear, up-to-date view of the entire product development lifecycle. This leads to common problems that directly impact your quality metrics:

• Inconsistent Processes: When information is scattered, it’s difficult to enforce standardized procedures, leading to deviations and errors.
• Lack of Collaboration: Functional groups struggle to work together effectively, causing misalignments between design requirements, risk analysis, and testing.
• Inefficient Workflows: Manual tracking and excessive paperwork consume valuable time, slowing down innovation and delaying time-to-market.
• Audit & Compliance Risks: Without a clear, traceable line from requirements to verification, proving compliance during an audit becomes a stressful, time-consuming scramble.

The key takeaway: Disjointed systems don’t just create inefficiency; they actively increase risk and make it harder to deliver high-quality, compliant products on schedule.

How to Improve Quality Metrics with a Modern Solution

Transitioning to a modern requirements management platform like Jama Connect provides a structured path to enhancing your quality metrics. It’s not just about new software; it’s about adopting a more integrated and transparent approach to product development.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Step 1: Establish a Single Source of Truth to Foster a Quality Culture

The foundation of any high-performing quality system is a single source of truth. When all functional groups, including engineering, quality, manufacturing, and more, collaborate within one platform, you eliminate confusion and create consistency.

Jama Connect provides this centralized environment where design requirements, risk management, test management, and design reviews are all interconnected. This ensures that everyone is working from the most current and approved information.

• Benefit: Teams follow procedures correctly because the system guides them through structured workflows.
• Impact on Metrics: Reduces errors, rework, and inconsistencies, allowing you to hit project deadlines.

Step 2: Leverage Live Traceability™ to Reduce Risk and Ensure Completeness

Passing an audit requires demonstrating that every requirement has been addressed from a risk management perspective, verified and/or validated, and properly reviewed., Manually creating and maintaining traceability matrices is prone to error and incredibly time-consuming.

Live Traceability in Jama Connect automates this process. It creates a real-time, dynamic map that links every requirement to its corresponding tests, risks, and design reviews. If a requirement changes, you can instantly see the downstream impact on testing and risk mitigation.

• Benefit: You gain complete visibility into your project’s health and can prove compliance with a few clicks.
• Impact on Metrics: Drastically reduces audit preparation time and minimizes the risk of findings. It ensures 100% test coverage, directly improving product quality and safety.

Step 3: Streamline Product Development with Out-of-the-Box Compliance

Meeting medical device regulations like ISO 13485, FDA QSR (soon to be QMSR), ISO 14971, and IEC 62304 demands meticulous documentation and adherence to specific processes. Jama Connect helps you streamline this with pre-configured frameworks and workflows designed specifically for medical device compliance.

Instead of building your compliance structure from scratch, you can use these out-of-the-box solutions to get a head start, ensuring your Medical Device File is built correctly from day one. All information can be easily exported into submission-ready documentation for your Quality Management System (QMS).

• Benefit: You can reduce paperwork and focus your team’s efforts on innovation rather than administrative tasks.
• Impact on Metrics: Accelerates project timelines and increases the likelihood of achieving regulatory approval on the initial submission.

RELATED: Accelerate the Development of Safe and Effective Medical Devices & Life Science Products with Jama Connect

Step 4: Boost Efficiency and Consistency with Reuse

Do your teams develop multiple versions of a similar product or use common components across different devices? Rewriting and re-verifying or re-validating the same requirements and test cases is a major source of inefficiency.

Jama Connect features powerful libraries that allow you to store, manage, and reuse requirements, risk analyses, and test cases across multiple projects. When an item in the library is updated, the changes can be synced to all projects that use it, ensuring consistency.

• Benefit: Saves significant time, reduces the risk of inconsistencies, and frees up engineers to focus on innovation.
• Impact on Metrics: Improves development efficiency, reduces costs, and ensures a standardized level of quality across your entire product portfolio.

FAQs: Improving Quality Metrics with Jama Connect

Q: How does Jama Connect specifically help with FDA compliance?

A: Jama Connect helps you adhere to FDA design control regulations like 21 CFR 820.30 by enforcing design controls within a structured environment. Its Live Traceability feature is critical for demonstrating the link between design inputs, outputs, verification, and validation. The platform also simplifies the creation and management of your Design History File (DHF), making it audit-ready at all times. For more details, see our guide on FDA Design Controls.

Q: Can we use Jama Connect without completely overhauling our existing toolchain?

A: Absolutely. Jama Connect is designed to integrate with popular engineering tools (e.g., Jira, Azure DevOps, TestRail). It acts as the central hub for requirements and risk management while allowing your teams to continue using the specialized tools they know best, creating a connected, best-of-breed toolchain.

Q: How does this platform help us use quality as a competitive advantage?

A: By streamlining compliance and improving process efficiency, Jama Connect allows you to get safe, effective products to market faster. This speed, combined with reduced development costs and lower compliance risk, gives you a significant edge over competitors who are still bogged down by manual processes.

Take Control of Your Quality Metrics

Stop letting disjointed systems and manual processes slow down your projects. By embracing a modern, integrated approach, you can improve your quality metrics, pass audits with confidence, and empower your teams to deliver innovative medical devices safely and efficiently.

Ready to see how you can transform your quality management process? Request a personalized demo of Jama Connect today.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish, McKenzie Jonsson, and Mark Levitt.

In this blog, we recap a section our recent datasheet, “Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect” – Click HERE to read it in its entirety.

Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect

Postmarket surveillance (PMS) is an expected regulatory activity that plays a vital role in ensuring the safety and effectiveness of medical devices after they reach the market. The key to an effective PMS program is to ensure that the requirements and risks identified early in the development process are continually updated throughout the product’s lifecycle. Maintaining “living” design documentation allows companies to better identify, analyze, and respond to potential safety issues. As new information about the product comes from user feedback, clinical studies, or complaint reports, teams can review and update all product information in Jama Connect, allowing them to conduct better investigations and continually enhance the product as a benefit to patients.

Jama Connect for Medical Devices streamlines and simplifies the PMS process by providing a single source of truth for a product’s entire lifecycle. Whether it is managing requirements, performing risk analyses, or conducting effective change management, companies can meet all regulatory requirements and provide patients with safer and more effective devices.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

KEY BENEFITS:

• Improve Postmarket Surveillance by Using the Same Platform During Development and Post Launch: Jama Connect is a full lifecycle platform that allows companies to manage requirements, testing, and risk analyses both during development and after launch, ensuring all PMS activities are managed efficiently and reliably.
• Enhance Risk Management Through Structured Collaboration: Build or easily migrate risk management items into Jama Connect so that internal and field-based teams can work together to collect and analyze product safety information and implement better corrective and preventive actions faster.
• Modernize Change Management by Maintaining a Living Design Documentation File: Create a real-time view of all product design and risk information in Jama Connect and utilize automated workflows to conduct change management activities.

Seamlessly Transition from Development to Surveillance

Jama Connect’s ability to create Live Traceability™ across your development tool chain ensures that every step, from ideation to postmarket adjustments, is documented and traceable.

Organizations that use Jama Connect for managing requirements, tests, and risk during development and postmarket surveillance can conduct investigations and implement product changes with greater speed and confidence to minimize the impact on patients and the company.

Finding success in Jama Connect is not just limited to those starting a new project from scratch. A company with many existing projects can transfer all requirements and risk information using migration solutions and services provided by Jama Software. This will create a strong foundation that helps the organization enhance postmarket surveillance activities and improve future development.

DOWNLOAD THE ENTIRE DATASHEET TO LEARN MORE:
Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect

In this blog, we recap our recent blog, “QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485”

QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485

Prepare for QMSR: Step-by-Step Guidance for FDA’s ISO 13485 Alignment

The FDA’s long-anticipated Quality Management System Regulation (QMSR) goes into effect in February 2026, marking a major shift by aligning FDA requirements with ISO 13485. This update presents both challenges and opportunities to streamline your quality processes while meeting new compliance expectations.

In this webinar, Steve Keverline, Principal Advisor at RQM+, and Tom Rish, Senior Product Marketing Manager at Jama Software, break down key changes, share strategies for companies at all stages of ISO 13485 adoption, and provide actionable tools to help you prepare.

Whether you’re just beginning your QMSR journey or fine-tuning a mature system, this session will equip you with the clarity and direction needed for QMSR success.

Key Takeaways:

• What is QMSR, why is the FDA aligning with ISO 13485, and what does this mean for your business?
• The key elements of ISO 13485 that are critical to QMSR-readiness.
• Strategies for both early adopters and seasoned organizations adjusting to QMSR-specific requirements.
• Best practices to align design control and risk management activities.
• Step-by-step insights, including leveraging integrated software tools to enhance risk management and traceability.

Don’t wait for 2026. Start preparing now to reduce risk, increase efficiency, and confidently lead your team through this regulatory shift.

Steve Keverline: Thanks to everyone in attendance of today’s webinar. My name’s Steve Keverline, I’m a principal advisor at RQM+, and today I’ll be walking through how to prepare for FDA’s alignment with ISO 13485. This is the QMSR initiative with an effective date of February 2026, so roughly six months away, quickly coming upon us and just highlighting that this shift really represents one of the most significant regulatory updates in, I’ll say, decades. So, really, the US medical device manufacturer was updated. Well, in 1996 was the large update. So, today’s goal is really to help understand what’s changing, what to expect, and how to prepare effectively for the transition to QMSR.

And what I have up here on the screen is an outline of what I will be covering today. I’ll be doing a little bit of background on the QMSR, well, more specifically, a little background on the QSR and 13485, just how they came about, and why they’re relevant to what we’ll talk about today. Why is FDA aligning with 13485, key elements to watch or maybe watch out for, and the transition timeline. Next, we’ll talk about the QMSR impact and adoption, so impact of this change will really vary greatly depending on the markets you currently sell into and really the maturity of your quality management system. So, we’ll touch on that. Certainly, if you’re selling into the US and not currently certified as ISO 13485, you have a heavy lift. If you’re already ISO 13485 certified currently selling in the US, then probably a little bit more administrative but we’ll cover those two scenarios.

And then just some implementation guidance, so just some thoughts on implementation best practices. So, one of the key pieces is integration of risk management and design control so we’ll spend some time on that, just really looking at how best to do that. Some common pitfalls, how to avoid them, and, finally, some tips on preparation and planning.

All right, QMS refresher. Yeah, so for those newer to medical devices or not yet familiar with the quality management system regulation, I thought it’d be beneficial just to step back a little bit and start with some background information on the quality system regulation, otherwise known as QSR or FDA 21 CFR Part 820. Compliance for the QSR is mandatory for commercializing a medical device in the US unless your product is identified or referred to as GMP-exempt. GMP-exempt is really applicable, really, only to lower risk, non-sterile medical devices, examples would be a tongue depressor, elastic bandage, manual toothbrush, bedpans, those type of low-risk devices. And even if GMP-exempt, there still are a subset of requirements like record keeping and complaint requirements.

The original, I’ll say original, the initial QSR took effect in 1978 and had significant revisions in 1996. And if you go back to those revisions, they were primarily due to product recalls that occurred in the field since the initial effective date back in … When it was originally released. And those recalls were primarily due to insufficient design controls and supplier controls so it became a big emphasis in 1996 to incorporate those elements within the QSR. Also, at the same time, ISO was starting to form, so the ISO committee had a draft of ISO 13485, and, go figure, the two just missed each other. So, the QSR came out, the ISO 13485 revision was published a little thereafter, so missed there in 1996. But you’ll see, and we’ll get into this a little bit more often as we go through this, but the ISO 13485 has evolved over time since then, there was a major update in 2003 and then a significant update in 2016. So, you can see that, while the QSR was a little stagnant, 13485 has been keeping up and has evolved over the last 30 years.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Keverline: When looking at the key set of requirements, the QSR tends to be a higher level set of requirements and not very prescriptive. When I’m challenged with interpreting the QSR, I have a colleague I work closely with, and she always says, “Well, let’s go to the preamble. Let’s really try to understand what FDA was thinking at the time.” So, not always obvious or intuitive, requires a little bit of what were they thinking, how do I interpret this with the QSR. [inaudible 00:07:19] come back here. And then 13485.

So, I touched on that a little bit in the last slide, 13485 provides a little more context regarding the requirements, is more prescriptive than the QSR. ISO, ISO stands for the International Organization for Standardization, so it’s different, it’s an independent non-governmental international organization. ISO publishes 13485 standards as well as other numerous system process product technical standards. Like I mentioned, the current version is March 2016, was published in March 2016, it’s titled Quality Management System requirements for medical devices intended for regulatory purposes and really covers the full product lifecycle. So, design and development, transfer, production, installation, servicing, really, throughout that full medical device useful life including post-market and decommissioning.

And also, ISO 13485 serves as really the foundation for most QMS frameworks outside the United States and certainly, in the European Union, it’s most recognized in specific to support CE marketing. So, key motivations, really, for FDA aligning with ISO 13485, it is the concept of harmonization. So, it didn’t happen back in 1996, had the best intent but it didn’t come together so here we are today with this initiative to align these two. And again, over the years, they’ve become more and more aligned with 2003 and then 2016 version. So this really means that manufacturers don’t need to maintain two sets of requirements. The regulations I mentioned a little bit earlier, a little outdated. So, QSR largely unchanged since 1996, a little static, 13485, definitely more dynamic and indescriptive, don’t need to go back to the preamble.

And there’s actually a really great … AAMI publishes a really great 13485 practical guide so, those that are new to 13485, really excellent, provides great examples and gives you a little bit more description on what the intent is. Efficiency for industry and FDA, so harmonization streamlines compliance, eliminating redundant efforts, this ultimately enables FDA to focus on risk-based oversight rather than duplicate inspections. Number four, regulatory clarity, so incorporating 13485 by reference provides a clearer, more direct international recognized framework. And it’s also important to note that there are some FDA specific requirements so, in some cases, there’s still FDA will take precedence over some of the 13485 requirements and we’ll get into that in a little bit.

Finally, number five, patient safety remains central. So, the FDA emphasizes the shift is not about relaxing standards, some may have perceptions that ISO 13485 audits are not as rigorous as FDA inspections. Certainly, these are coming together here and you can’t take any audit or inspection lightly. So, still very much about enhancing regulatory effectiveness while maintaining high standards for patient and user safety.

And this is it, tada, this is the QMSR, built that up for this slide. But on the left-hand side, you’ll see the QMSR, I’m sorry, the QS, the quality system regulation, QSR, so this is 820 as we know it and love it today. On the right-hand side, you’ll see a more abbreviated version, not to be perceived as a lighter lift. So, if you really start to dig into the details, the QMSR on the right, well, it’s smaller, it doesn’t look as scary, what you don’t see in any detail is section 820.7 which is incorporation by references so that is basically pointing to 13485 and ISO 9001 which contains terms and definitions but also 820.10 which contains a lot of the details, detailed requirements. So, there it is.

RELATED: Application of Risk Analysis Techniques in Jama Connect^® to Satisfy ISO 14971

Keverline: Yeah. Under QMSR 820.10, so briefly mentioned that, it basically, again, points to the applicable requirements of ISO 13485:2016. QMSR 820.10(b) gets into additional requirements beyond ISO 13485; these are defined as unique device identification, which is more explicit than ISO clause 7.5.8. Medical device tracking which is applicable to implantables, so more explicit than ISO clause 7.5.81. Adverse event reporting, more explicit than ISO clause 8.2.3. And corrections removals, which ISO 13485 refers to as advisory notices, more explicit as it relates to clause 8.3.3. These don’t necessarily equate to new US requirements; rather, I’ll say, putting the hooks into ISO 13485 and, overall, the QMSR.

Certain existing QSI provisions will still remain in effect. For example, for lower risk devices, FDA has chosen to exempt some of those devices from design controls. So, that still remains in effect. Complaint and servicing records, device labeling and packaging requirements, these still stay in effect as well, they are really augmenting the 13485 as it relates to specific information that’s required on those records. And as it relates to labeling and packaging, FDA did not believe ISO 13485 covered these requirements fully and a lot of that’s based on labeling which is frequently associated with recalls, mislabeling, mix-ups, that kind of thing. So, they expanded on 13485 requirement here.

And because we like exceptions, so there’s some new definitions to the QMSR, you see that on the left. So, component, Federal Food, Drug and Cosmetic Act, finished device, HCT/Ps, and remanufacture. And on the right, these terms are different in the QMSR than what you’ll find in ISO 13485 or ISO 9001 so, again, this is the case where they would take precedence. Implantable medical device, manufacturer, organization, rework, safety, and performance.

While expectation by FDA is that you’re looking at risks in your processes and prioritizing accordingly, it’s not explicitly stated in the QSR for many processes; this is a big part of 13485. So, 13485 really emphasizes a process-based approach, risk management throughout the product cycle, more prescriptive supplier management, and proactive post-market surveillance. And these are really the key areas to watch if you don’t currently have 13485 in place and are moving forward with the QMSR, just a few areas that could be a heavy alert, for sure.

So, the exhortation for documented procedures, ISO requires more formal documentation and some legacy A20 systems. Risk-based decision making, this really needs to be embedded throughout your quality manual system, not just in product design. Supplier management, ISO requires evaluation, selection, monitoring and re-evaluation of suppliers based on risk. So, that adds a little more level of scrutiny than what’s currently in the QSR. And post-market surveillance, so ISO expects a proactive approach, not just reactive complaint healing. So, these are areas where we’ll be under scrutiny, for sure, as it relates to QMSR.

And here’s the timeline. So, final rule was published January 31st, 2024; there was a comment period prior to that, similar to the preamble. There’s some good stuff in there if you want to read some of the pushback. We’ll get to a couple of those later, but it’s a good read. There was a two-year transitional period; the QMSR becomes effective and enforceable February 2nd, 2025. Here we are, sitting in August 2025, so roughly six months away. If you’ve not started yet, you really need to get going, especially if you do not have ISO 13485 in your QMS today.

To Watch the Entire Webinar, Including An Info-Filled Q&A Session, Visit:
QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485

In this blog, we recap our recent customer story, “Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process”

Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process Customer Story

Biofidelity chooses Jama Connect to enhance the process previously managed manually with Jira and documents.

Biofidelity, headquartered in Cambridge, United Kingdom, provides innovative technologies that unleash the potential of genomics for fast and accurate targeting and monitoring of cancer treatment.

Biofidelity was founded in 2019 with the goal of enabling millions of lives to be transformed through access to vital information needed for accurate targeting and monitoring of treatments for cancer and other illnesses. They develop innovative molecular technologies that remove the noise from genomic data to make analysis simpler, faster, and more adaptable. Healthcare providers, laboratories, patients, and biopharma firms rely on Biofidelity solutions to provide only the information needed to enable swift decision-making and ensure the best possible outcomes.

Biofidelity’s first product, Aspyre^® Lung Reagents, is a research use only (RUO) product that enables simple, fast, and reliable detection of established biomarkers in tissue or blood for use in non-small cell lung cancer research. It includes the lab assay and turnkey cloud analysis software designed to be integrated into a customer’s laboratory. The company’s second product, Aspyre^® Clinical Test for Lung, is a laboratory-developed test (LDT) that clinicians use to submit tissue or blood specimens to Biofidelity’s CAP-accredited, CLIA-certified lab for analysis with a quick two-day turnaround time from sample to result.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Challenges

• No automated change control and review process for requirements and tests
• Documentation preparation took seven to ten days every quarter
• Needed to be ready to adapt to changes in regulatory environment

Biofidelity’s competitive edge is in developing products offering simplicity, speed, low failure rates, and sensitivity. As a startup beginning to scale, the company developed their products using a combination of general-purpose platforms, manually tracking requirements and tests, and checking traceability. Managing this information across several documents in separate systems required manual connections, leading to lack of formal traceability between tools. Additionally, while the team could view the history of changes and comments in Jira, there was no established process for reviewing and approving requirements. Significant effort was needed to correctly gather the approved content for release documentation.

For each quarterly product release, the company needed to ensure that all actions were complete and that all information was accurate. However, using Jira made it extremely challenging to consolidate and display all the requirements, test items, and their upstream and downstream relationships. Jira only provided a basic draft table of user needs for verification and left the validation process to be handled manually using a spreadsheet.

The resulting process of generating documents took seven to ten days each quarter. “When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming,” said Adam French, Associate Director of Software & IT, Biofidelity.

Although mandatory FDA oversight of LDTs were originally slated for 2025, Biofidelity demonstrated foresight by recognizing the need to stay ahead of the evolving regulatory landscape. They took proactive steps to improve their product development processes to ensure they could demonstrate compliance.

The need for better processes was driven by the company’s aim to make Aspyre technology accessible to millions of people affected by cancer each year, which requires the ability to adapt to new target markets more
quickly and easily.

When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming. – Adam French, Associate Director of Software & IT at Biofidelity

RELATED: Jama Connect Features in Five: SaMD Framework

Evaluation

• Alignment of requirements with Jira issues
• Automation of requirements and tests change control
• Process for reviewing and approving requirements
• Faster generation of documentation

The company initially set out to find a test management system. However, they quickly discovered that general-purpose project management software, even with plugins, lacked features for requirements management, collaboration, and traceability. In searching for application lifecycle management systems for medical device development, they found Jama Connect, MatrixALM, and Visure Requirements.

After an evaluation involving the software development team, Jama Connect was chosen for its superior configuration, control, and review of changes, and documentation capabilities. Jama Connect and its Software as a Medical Device (SaMD) framework offered flexibility and a depth of configuration that included templates and pre-configured out-of-the-box item types that closely aligned with the team’s existing Jira issues.

The team valued how Jama Connect offers efficient and reliable control over changes to requirements and tests through traceability. In Jama Connect, impact analysis identifies all upstream and downstream traced items affected by a change. Additionally, suspect links are automatically created after changes are made to designated fields, flagging all downstream requirements that may no longer be accurate, complete, or verified.

“Adding control of changes and relations between all item types was the most important thing for us. You can put relationships between Jira issues, but it doesn’t give you the suspect link notification, review process, or control to check upstream and downstream items after you change a source item,” said Max Artomenko, Software Engineer, Biofidelity.

Aside from the Jama Connect product, there were two other reasons for the choice. The Jama Software team spent a significant amount of time answering and asking questions that went to the heart of what the Biofidelity team needed. In addition, a member of the software development team had previous practical experience of how Jama Connect could be effectively integrated into the software development process.

RELATED: QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485

Outcomes

• Reduced documentation preparation time by 33 – 50%
• Increased standardization and automation of requirements change control
• Development process that’s ready for dynamic regulatory
• Ability to expand into risk analysis and additional teams, products, and markets

With Jama Connect, Biofidelity has reduced documentation preparation time for each release from seven to ten days down to two to three days, a 33-50% reduction. More importantly than the time savings, the team remains confident that the information is correct and ready for FDA audits due to the automated traceability, suspect link notifications, and review processes in Jama Connect.

Jama Connect has standardized how and where all the different teams create and store content. That helps ensure the team is alerted when changes are made and manage changes to team makeup. “Most important for the company is to have one source of truth for all user needs relating to software and hardware requirements, even when the teams change,” said Artomenko.

Unlike in the past, the team can do its traceability analysis in Jama Connect at any moment, even during development. This provides greater control of changes that affect the state of software requirements.

The company successfully transitioned their issue types from Jira into Jama Connect item types and experienced improvements in managing them. The plan is to further expand the management of requirements and tests in Jama Connect by incorporating risk management using the FMEA item type, which is readily available in Jama Connect’s SaMD framework.

By shifting risk analysis from Excel to Jama Connect, the team anticipates gaining more efficient control over risks, including immediate ways to demonstrate that all risk items have mitigations that are implemented and tested.

While the software team was the first to use Jama Connect, additional R&D teams are evaluating Jama Connect to potentially manage their user needs, requirements, and tests for other related products. Jama Connect’s support for reuse of existing requirements and tests could translate into faster development of new products and entry into new markets. “One of the key advantages of Jama Connect is that it improves our processes and makes it easier for us to move into new markets and adapt as regulations change,” said French.

“As we move into a regulated space in the future, we expect to be audited more frequently. With the help of Jama Connect’s SaMD framework, we are getting ready to be able to demonstrate that the quality is there every time.” – Adam French, Associate Director of Software & IT at Biofidelity

DOWNLOAD THE ENTIRE CUSTOMER STORY HERE:
Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process

Preparing for the FDA’s QMSR: Your Guide to Compliance Success

“The only constant in life is change.” Those words, often attributed to the Greek philosopher Heraclitus, seem especially true in the medical device industry. Industry veterans have experienced a constant evolution of the regulations over the past 10 years. There was the update to ISO 13485 in 2016, the new EU MDR in 2017, changes to ISO 14971 in 2019, and now it’s the FDA’s turn.

In a long anticipated move toward global harmonization, the FDA has finalized its transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR). This shift, effective February 2, 2026, marks a significant evolution in how medical device manufacturers will be regulated in the U.S. As with any regulatory change, it presents challenges, but also provides opportunities for companies to become more efficient and stand out amongst their peers.

Whether you’re a startup building your first quality system or an established manufacturer already certified to ISO 13485, understanding the nuances of QMSR and creating a robust plan can help you not only stay compliant but also build a stronger, more competitive organization.

What is the QMSR?: A New Era in FDA Compliance

The QMSR is the FDA’s updated framework for medical device quality systems. It replaces 21 CFR Part 820 (QSR) and incorporates ISO 13485:2016 by reference as the foundational standard for compliance.

This alignment is designed to:

• Harmonize U.S. regulations with international standards.
• Reduce regulatory burdens for global manufacturers.
• Promote faster access to safe, effective, high-quality devices.

Along with the major structural shift of incorporating ISO 13485, here are some other differences between the QSR and QMSR:

• Terminology Updates: QMSR replaces legacy terms like “Device Master Record” with ISO equivalents such as “Medical Device File.”
• Risk Management: QMSR emphasizes risk-based thinking throughout the product lifecycle, whereas QSR limited risk management to design validation.
• Record Accessibility: QMSR mandates that internal records (e.g., management reviews, audits) be available for FDA inspection even though they were previously exempt under QSR.
• Supplier Controls: QMSR requires documented supplier qualification and performance monitoring, enhancing QSR’s basic evaluation standards.
• CAPA Enhancements: QMSR strengthens corrective and preventive action systems with trend analysis and effectiveness verification.
• FDA-Specific Supplements: QMSR includes additional requirements to ensure consistency with the FD&C Act, such as complaint handling and UDI compliance.

RELATED: INBRAIN Chooses Jama Connect^® to Provide Clarity, Stability, and Confidence in Quality Control for Neural Implant Systems Development

How QMSR Compares to ISO 13485

Since ISO 13485 provides the foundation of the new QMSR, companies that are ISO 13485 certified, or on their way to implementing it, will find themselves in a good position when transitioning.

However, the QMSR isn’t simply ISO 13485 renamed. While the two are 90–95% aligned, QMSR introduces FDA-specific requirements that companies will need to look out for when creating a plan to comply. It is also important to note that FDA definitions take precedence over ISO terms in case of conflict.

For a detailed breakdown of the new QMSR and how it compares to ISO 13485, check out this webinar, QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485. In the meantime, here is a quick rundown of the similarities and differences:

Key Similarities:

• Risk-Based Thinking: Both emphasize integrating risk management throughout the product lifecycle.
• Process Validation: Strong focus on validating critical processes and software.
• Supplier Controls: Requirements for evaluating and managing suppliers.
• Management Responsibility: Top management must foster a culture of quality.

Key Differences:

• Terminology Adjustments: QMSR removes some terms like DHF, DHR, and DMR, but retains FDA definitions for terms like “device” and “labeling”
• Expanded Traceability: ISO 13485 focuses on implantables; QMSR extends traceability to devices that sustain or support life
• Labeling and Packaging Controls: QMSR introduces detailed requirements under §820.45, going beyond ISO’s general guidance
• Recordkeeping and Accessibility: QMSR adds signature/date requirements and mandates that records be readily available for FDA inspection, even if stored offsite
• FDA Inspection Scope: ISO certification doesn’t exempt companies from FDA inspections. QMSR maintains FDA’s authority and introduces broader inspection access

RELATED: Navigating the New DOGE Impacted FDA: How MedTech Companies Can Build a Competitive Advantage

Preparation Strategies for Different Company Types

If You’re a New Company Building Your First QMS

Start with Risk-Based Thinking

Implement integrated risk management from day one of your product development lifecycle. This means considering risk at every stage, from initial concept through post-market activities. Your QMS should demonstrate how risk management influences design decisions, manufacturing processes, and post-market surveillance activities.

Establish Clear Documentation Practices

Create documentation systems that scale with your organization. Digital platforms that provide traceability, version control, and automated workflows will serve you better than paper-based systems as you grow. Consider how your documentation will support FDA inspections and ensure all required records are easily accessible.

Build Culture of Quality Early

Establish quality-focused culture from your company’s foundation. This means training all employees on quality principles, establishing clear quality objectives, and ensuring leadership demonstrates commitment to quality in both words and actions.

For Established Companies with ISO 13485 Compliance

Conduct Comprehensive Gap Analysis

Review your current ISO 13485 implementation against QMSR-specific requirements. Pay particular attention to areas where the FDA has added clarifications or additional requirements beyond the standard.

Update Training Programs

Ensure your team understands both ISO 13485 requirements and FDA-specific additions. This includes understanding how the FDA interprets certain requirements and what inspectors will look for during assessments.

Enhance Documentation Traceability

While ISO 13485 requires traceability, FDA expectations around documentation completeness and accessibility are particularly stringent. Ensure your systems can demonstrate clear linkages between requirements, design outputs, verification activities, and post-market data.

For All Companies

Don’t Wait to Create a Transition Plan

The FDA’s QMSR transition deadline is February 2, 2026, and companies that delay preparation risk falling out of compliance. Starting early allows time to conduct gap analyses, update documentation, and train teams without the pressure of looming deadlines.

Engage with Industry Experts

Consulting firms with regulatory expertise can help identify areas where your current quality system may not meet QMSR requirements. They can also conduct mock audits and provide targeted training to ensure your team is inspection-ready.

Monitor FDA Updates

The FDA is actively revising its inspection protocols and guidance documents to reflect the new QMSR framework. Staying informed about these updates ensures your compliance strategy remains aligned with the latest regulatory expectations.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

How Jama Connect^® Facilitates QMSR Transition

Navigating the new QMSR requires robust systems that support traceability, collaboration, and documentation throughout your product development lifecycle. Jama Connect provides the digital foundation necessary for successful QMSR implementation and long-term compliance maintenance.

Full Lifecycle Live Traceability

Jama Connect’s traceability matrix capabilities ensure complete visibility from user needs through design outputs, verification activities, and post-market surveillance. This end-to-end traceability is essential for demonstrating QMSR compliance during FDA inspections and supports efficient change management processes.

Built-in Regulatory Templates

Pre-configured templates for ISO 13485 and FDA requirements accelerate your compliance efforts. These templates provide structured approaches to requirements management while ensuring you capture all necessary information for regulatory submissions and quality system documentation.

Risk Management Integration

Jama Connect’s risk management capabilities enable you to capture, assess, and manage risks throughout your development process. Integration with requirements and design documentation ensures risk considerations remain visible and actionable throughout your product lifecycle.

Collaborative Quality Culture

The platform’s real-time collaboration features support the Culture of Quality that’s central to QMSR success. Team members across different functions can contribute to quality processes, ensuring quality considerations are embedded throughout your organization rather than isolated in quality departments.

Automated Reporting

Generate compliance reports efficiently with automated documentation features. This reduces manual effort while ensuring consistency and completeness in your regulatory submissions and quality system documentation.

Ready to streamline your transition to QMSR compliance? Discover how Jama Connect can support your transition with comprehensive traceability, integrated risk management, and collaborative reviews. Start your free trial today or schedule a demo to see how digital transformation can accelerate your regulatory success.

In this blog, we recap our recent webinar, “Simplify Airborne Systems Lifecycle Milestones with Categories”

Simplify Airborne Systems Lifecycle Milestones with Categories

Gain Clarity, Reduce Risks, and Stay Compliant.

Struggling to keep track of deliverables across complex aerospace projects? You’re not alone. Managing deadlines and milestones often feels like navigating a maze of documents, spreadsheets, and shifting priorities.

In this webinar, you’ll discover how Jama Connect^®’s Categories feature can bring order to your milestones, improve transparency, and align deliverables with key compliance standards like ARP4754.

What You’ll Learn:

• How to Enable Categories: Simplify system development milestone tracking from start to finish.
• Clarity on Deadlines: Learn how to make engineering deadlines easier to understand and act on.
• Improving On-Time Performance: Organize milestone deliverables and optimize workflows to avoid delays.
• Compliance Alignment: Map development milestones to standards such as ARP4754 with ease.

VIDEO TRANSCRIPT

Patrick Knowles: I’m Patrick Knowles. It’s great to meet all of you. Today, we are going to be looking at simplifying airborne systems, specifically lifecycle milestones, by using Categories in Jama Connect. As I mentioned, my name is Patrick Knowles. I’m a senior solutions consultant here. And it’s just a pleasure to work with y’all. I’m in our aerospace and defense vertical, so my expertise comes from that within the industry. And now I’m happy to be sharing that with you all as I work through consulting, as well as webinars. Today’s agenda, we’re going to tackle really the core problem, the complex challenge of milestone deliveries. From there, I’m going to introduce this category’s functionality and features to all of you. If it’s something you’re familiar with, this will be a breeze. If it’s something new to you, I hope this is a great introduction to how it works.

Then we’ll talk about how you categorize information specifically with some best practices. So, for even those who are used to using Categories, this should be a refreshing little bit with maybe some new tricks that you can utilize. And then finally, we’re going to talk about deploying this to your collaborative teams, which is really critical. Because if the data’s Categorized on day one and then the data changes or new data comes in, your teams are going to need to know how to manage this, how to look at the information. And it’s going to help solve that complex challenge of milestone delivery and some of the issues that we’re going to talk about there.

So, this complex challenge, deadlines, and stress. There’s data everywhere. It’s disconnected, it’s disparate, it’s annoying. That’s the core root problem here. But to elaborate on it, engineering in the digital age can feel like a maze. There’s sometimes a lack of top-down visibility to deliverables. So, if you’re a program manager or a lead systems engineer or a chief engineer, you might struggle to see all the work that your teams are doing. And sometimes there’s a lack of bottom-up visibility to the milestone. So, if you’re an engineer, you might not know about what milestone comes next, what’s due at that milestone. A lot of the time, that information is on a Word document or an Excel sheet, or maybe a Confluence page at best, where it’s listing out everything that’s due, but it doesn’t inherently connect to anything that is due and what those exact bits of information on.

And that leads to some unclear methods for contributing. How do I, as an engineer, ensure that we’re going to meet this deadline? I know what I see on my scrum board or I see from my manager, or whatever it might be, but maybe at the end of the day I don’t really understand exactly how my little bit of data is getting into that greater picture for this delivery to our customer or to our internal stakeholders. And then, of course, the common issue is always that data is disconnected, but that’s what Jama Connect is here to help with. We’re here to help you guide through that maze and to connect your data together to solve these key issues.

So, the risky scenario here is that your data is disconnected from a milestone, and that maybe you forget to deliver a certain part of the data, or you deliver outdated bits of data, or anything else that might happen there. And it’s pretty common across engineering. It doesn’t really matter where you work, there’s always this struggle to get everything ready from pencils down to delivery or whatever it might be. There are bigger views related to all of this work. There are stakeholders, customers, and, of course, the program leaders who need to see this information. And they need to see the most up-to-date, correct information. And without a clear way to connect your requirements specifically, because that’s what we’re going to mostly talk about here, is requirements. But without a really clear way to connect your requirements to your milestones or the rest of your data to milestones, you run the risk of simply leaving things behind.

RELATED: Jama Connect Airborne Systems

Knowles: So, how can Jama Connect help? Well, the specific use case we’re going to talk about today is enabling our Categories functionality in the tool. And we’re going to line it up with milestones from regulatory documents. Specifically, this example is going to be based on ARP4754B. However, if you are running the NASA systems engineering life cycle and you know the milestones in there, you could also line this up to that or any other number of product lifecycle milestones. We’re going to categorize data directly into things. And that’s going to help you really line it up to each of these listed items over there in the screenshot on the right. And then your members of the team are going to be able to filter, and view this data, and see it grow and add to it. And it’s going to be very transparent for them, how they’re connecting their information to the greater milestone.

With our foundation laid, there on what the problem is, I want to talk more about what Categories are. So, what exactly is a Category? Why do we believe this is a great option for you and the team to try and enable within your tool? Specifically, Categories have a similar feel to some other features within Jama Connect, like tags and pick lists. However, Categories win out overall with this specific use case for a number of reasons. First and foremost, Categories are admin-enabled and controlled, so your general user can’t populate a Category. They can assign information to a Category, but they can’t create new ones. Which means that, unlike tags, this is a kind of configuration managed by your admins. Pick lists are also configuration managed by your admins. However, they aren’t globally accessible to all item types. You’re going to have to create a field for every single pick list that you want assigned different item types.

Categories, however, can be globally applied to an entire project or to the whole instance of Jama Connect. That means that you don’t have to go and assign them to each of your item types. They’re going to connect to folders. They’re going to connect to texts. They’re going to connect with your specific requirement types, whatever it might be. And so, that’s an advantage that Categories have. Also, Categories can be available across multiple projects or just one specific project, which helps if you have a kind of multi-layered approach to your Jama Connect development of requirements. Finally, I’ll explain why not to use tags and pick lists. Tags, again, are creatable and by the user, and prone to error. If you type a capital letter in the wrong spot or put the wrong vowel in the wrong place, that’s going to be there in perpetuity, unless you have really strong tag cleanup processes.

And pick lists and multi-selects, you have to create it for each item type. You have to maintain the pick list. And then if an item type is introduced to a project, you’re going to have to re-add that pick list to it, and so on and so forth. So Categories is a little broader, but also just as controlled. And so, you’re able to kind of manage in a smoother way. So, how do you set up Categories? Well, you go to admin, Categories. And then over there on the far right of the screenshot, you’ll see enable Categories is turned on. It’s defaulted off for most instances, so make sure you turn it on first. From there, we’re going to set up all the Categories you see in front of you on the screenshot, as well as any number of other Category you may want to enable.

RELATED: Jama Connect Features in Five: Categories for Milestones

Knowles: Now, once you’ve got everything enabled, it’s all about how do you Categorize the information. So, we’re going to walk through some instructions, some best practices, and then we’ll do some demonstration, of course, here at the end of this section of the slides on how you do all this work. The first thing, like we mentioned, is enabling Categories. You do that through the admin. You assign things to either projects or global within your Jama Connect instance, and then you start utilizing them. One of our best practices here is to manage Categories through logical organizers, so folders, sets, components. That allows you to then click into the list view of that logical organizer and then assign all the Categories to the items within it. You don’t have to do this. This is just one of the more efficient ways, especially if you’re enabling an architecture-forward approach within your database. And of course, you can manage Categories in bulk, otherwise this whole explanation wouldn’t make much sense.

So, some of the tips, tricks, and best practices. Here, we’ve got the managing in bulk. And I’ll show you how to do that live. We’ll view categorized information in the exploratory via a filter, and so we’ve got to set up filters. Of course, those same filters can be exported or sent to reports, and then you can use multiple Categories on the same item. So, if one item is going to be delivered at the first milestone and you want to continue to deliver it at the next milestone, you simply add both Categories to it. And finally, you can always create baselines of everything filtered. So, these filters that we’re going to use to shrink down and narrow down the exploratory are also going to be very, very useful for baselining, for exporting, and for a number of other things.

So, now it’s time to demonstrate some of these best practices. The first things first is enabling Categories. As we discussed earlier, there’s this enable Categories button here on the far right. Once enabled, you’ll be able to add Categories with the add button here. Doing that is as simple as populating a single field with the information and hitting add. I, of course, have the whole system ddevelopment phase added already, and so I want to show you exactly what that looks like, how these things got nested underneath each other, and so on and so forth, by adding an eighth step. So, for today, the webinar phase is what we’re going to add to our development phases here. When we add, it’s going to actually add it at the top level. And so, then we need to drag it down into the system development phase.

We are going to use the move functionality here, as that’s the best practice in this scenario, where the copy Category functionality is better for using this for variant management. Now you can see that the webinar phase has been added to the system development phases. And you can also see that the system development phase is a project Category. This was done by managing access here on the right side, where you can pick the specific projects you’d like this Category to be assigned to. Or if this is something you want globally accessible, you can use the globally accessible button here. When you hit that, you’ll see that it turns orange and has a globe, instead of the project specific icon that you saw originally.

Now let’s look at how we categorize information within the tool. Our screenshots were showing this functions portion of this project, and so we’re going to dive into that to continue the continuity of this example. This specific set here, we’ll view the details of it, and we’ll simply scroll down and manage Categories. So, if we wanted to add that eight system development phase, webinar phase, we’ll simply select it, and click add and it will be added to this set of information. From there, we can bulk edit everything underneath the set by selecting all the items and clicking manage Categories. Same pop-up shows up, and we’re able to add that eighth phase of the lifecycle.

Now, this is really, really fantastic. If we want to go see everything in the eighth phase of the lifecycle, we can select the Categories feature over here. We can expand our system development phase and select webinar phase, where we see the items that were added there, including the set up here, and are able to kind of view this information in the list view. Now, if we wanted to see this in the explorer, we would go to filters and we’re just going to rely on this pre-built one here. And we’re going to right click apply filter to explorer. This is going to show us the information in a more succinct way. And we’ll talk more about this as we go on.

RELATED: Simplify DoD Program Work Breakdown Structure Compliance with Jama Connect for MIL-STD-881 Engineering

Knowles: Now that we’ve looked at how to enable Categories, we want to talk about how we develop this and deploy this data and these Categories for your collaborative team. I talked a little bit about this and showed you these exact steps here to narrow down your explorer tree, but what really is the benefit here? Well, you can set up a simple filter that’s based on the Category itself and right-click apply that filter to the explorer. This lets teams see just the information they need to care about coming up, especially if your sets, components, and folders are all categorized. This will show a team that, hey, we need to make sure all of the aircraft functions are populated for this coming milestone, because that set is there. Same with the aircraft validations, the requirements, and the plans and assessments.

Each of those logical organizers are categorized, showing the team this is something that is due at the upcoming milestone. The team then will populate information underneath that and they will categorize those items as well to bring them into the overall filter. Now, public filters are just kind of one of the ways we want to see this deployed to the team. We also need to demonstrate to the team how do you bookmark the filters, and how do you even manage Categories in general? So, in the next step here, I’m going to demonstrate managing Categories for single items, as well as a couple other little nuances within the tool that the teams will need to understand as they go ahead and use this in the deployed environment.

When deploying this information to the teams, it’s really critical that you’ve set your filters to be public. A quick way to note if something is public is if it’s got the asterisk next to the name here. You can always right-click and edit your filter and click the make public, and that will denote that it is public to all users using this project. Once your filters are all built out, you’re going to have them there. You’re going to teach your users exactly how to use them, of course, with the apply filter to explore. But also, if they need to send these for a review and get signatures on them or add a baseline, there’s also these features available to them.

And of course, bookmarking is really, really critical. Without it bookmarked, you can see I’m now missing phase one, so I have to go to all, and then go find phase one, and add it to my bookmarks and it’ll now show up in my bookmarked section here. Users most of the time are going to be adding new items to the tool. And so, if we add a new item here, we’re going to populate this new item, a new item for webinar. And that’s going to be our example item here to show that once we’ve saved it, this is when we get to add the Categories. It’s not a field that’s available directly when editing a brand new item. It shows up after the fact here down at the bottom with the managed Categories button.

You’ll then grab the applicable Categories that you want to add to this item, save it, and you’ll see them here. This helps, and it automatically adds things to the filter. You’ll see here that we’ve gone up in the number of items, and our new item for the webinar right here is now part of the filter automatically. Additionally, you can show your users that they can come directly here in the category section to see the same information, just without the filter and without some of those right-click functionalities that you get to see when you’re in the filter section. It’s been fantastic to work with you all today and show off these features in the tool.

WATCH THE ENTIRE WEBINAR HERE:
Simplify Airborne Systems Lifecycle Milestones with Categories

Artificial intelligence (AI) and machine learning (ML) are transforming industries across the globe, and the medical device and life sciences sectors are no exception. Today, the development of complex medical devices is being accelerated and optimized with the integration of responsible AI. From enhanced product design to improved compliance and streamlined workflows, AI is allowing teams to accelerate their workflows.

This blog aims to explore the expected impact of AI on medical device development — including current industry trends, regulatory considerations, and how companies like Jama Software are empowering organizations to leverage AI responsibly.

Types of AI Medical Devices

AI medical devices are rapidly transforming healthcare by introducing advanced diagnostic, therapeutic, and monitoring capabilities. Among the 950 AI-powered medical devices currently identified, several core categories stand out:

1. Diagnostic Tools: AI-driven diagnostic devices are designed to assist in identifying diseases and conditions with greater accuracy and efficiency. These include imaging systems equipped with machine learning algorithms to detect abnormalities in X-rays, MRIs, and CT scans, as well as AI software for analyzing pathology reports or genetic data. Such tools are especially beneficial in early disease detection, reducing diagnostic errors, and improving patient outcomes.
2. Monitoring Devices: Another significant category is AI-enabled monitoring devices. These systems continuously track patient vitals, such as heart rate, blood pressure, glucose levels, or oxygen saturation, and can alert healthcare providers to early warning signs of complications. Wearable sensors and remote patient monitoring platforms powered by AI are playing a crucial role in providing real-time health insights, especially for chronic disease management.
3. Therapeutic Systems: AI-powered therapeutic devices support or enhance treatment strategies. Examples include robotic surgery platforms with AI for precise surgical execution, as well as AI software that tailors treatment plans using patient-specific data. These systems are helping doctors optimize therapies and deliver more effective and personalized care.
4. Decision Support Applications: AI-based decision support tools are designed to assist clinicians in making informed decisions. These devices analyze vast amounts of medical data to provide evidence-based recommendations or predict potential complications. They are widely used to guide treatment strategies and manage complex conditions with a data-driven approach.

By focusing on these categories, it becomes clear that AI medical devices are not only advancing the standard of care but also addressing critical gaps in healthcare delivery through innovative applications of artificial intelligence.

Medical device manufacturers are leveraging AI and ML in several groundbreaking ways. The U.S. Food and Drug Administration (FDA) has already approved over 950 AI-enabled medical devices as of mid-2024. This reflects a dramatic rise over the past decade and highlights the growing adoption of AI technologies. Here are key areas where AI is making a difference in medical device development:

Current Regulations for AI and ML in Medical Device Development

While the potential of AI is evident the successful adoption of these technologies requires adherence to evolving regulatory frameworks. The FDA has been actively addressing the need for guidelines in this space, ensuring a balance between innovation and safety.

FDA Guidance and Regulations

The FDA oversees AI-enabled devices through various pre-market pathways, including:

• Premarket Notification (510(k))
• De Novo Classification
• Premarket Approval (PMA)

To accommodate the complexities associated with adaptive AI/ML-enabled devices, the FDA has released multiple resources, such as the 2024 Artificial Intelligence and Machine Learning Action Plan, which outlines the agency’s vision for regulatory oversight. Key highlights include:

• Development of Good Machine Learning Practices (GMLP).
• Introduction of frameworks for Predetermined Change Control Plans, allowing for post-market updates to AI systems without requiring new approvals.
• Enhanced transparency for AI-powered medical devices.

New FDA Guidance: To learn more about recent guidance provided by the FDA, read these two articles:

• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

Global Considerations

Beyond the U.S., regulatory developments in Europe, including the EU AI Act and MDR compliance, are impacting how organizations worldwide approach AI implementation in medical devices.

Staying compliant demands robust traceability, stringent risk management protocols, and adherence to data security standards.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Trends and Insights for AI-Powered Medical Device Development

The trajectory of AI in medical device development is poised to grow exponentially, driven by several key trends:

Shift to Software-Defined Devices

Medical devices are increasingly becoming software-centric. Traditional hardware is giving way to platforms that can be continuously enhanced through software updates.

Integration of Generative AI

Generative AI algorithms are now being used by medical device manufacturers to create simulations, generate testing data, and optimize device designs. Companies like NVIDIA are spearheading this trend with platforms supporting robotics and digital surgery.

Rise of Collaboration and Ecosystem Growth

Partnerships between MedTech companies, academic institutions, and tech giants are fueling innovation. Startups like Moon Surgical and Aidoc demonstrate how collaborations can lead to cutting-edge AI implementations in laparoscopy and diagnostic tools.

Broader Applications Beyond Radiology

While radiology remains at the forefront, AI is expanding rapidly into fields like:

• Neurology: Detecting brain activity anomalies.
• Cardiology: Spotting arrhythmias through AI-powered stethoscopes.
• Oncology: AI-enabled tools for precision cancer diagnosis.

RELATED: Industry-leading Practices Modernize Legacy Public Health Software System, a Deloitte Customer Story

Jama Software’s AI Initiatives for Medical Device Development

With the rise of AI-enabled medical devices, Jama Software is focused on how organizations can incorporate AI applications in their product development processes to improve quality and accelerate development. Here are a few example use cases Jama Connect^® is focused on:

Jama Connect Advisor™

Jama Connect Advisor analyzes your product requirements against industry standards such as INCOSE Rules and EARS Notation, then recommends improvements. This fast, accurate analysis and advice helps your requirements align with engineering-focused natural language and best practices.

Benefits of using Jama Connect Advisor:

• Improves the quality, accuracy, and usability of your requirements across your organization.
• Assists development teams in standardizing the process and language of requirement authoring.
• Saves time for authoring, reviewing, and updating requirement statements.
• Helps deliver programs and projects on time and on budget.
• Reduces the risk of late-stage errors.

Test Case Intelligence

Streamline verification and accelerate to market with AI-generated test cases derived from requirements.

Intelligent PDF Parsing

Quickly parse PDFs and Office files, match to existing IP, or generate new requirements for review and collaboration. AI enhances reuse, speeds RFPs, streamlines supply chain collaboration, and boosts product quality.

Learn more about Jama Software’s AI initiatives by visiting: https://labs.jamasoftware.com/

Transforming the Future with Responsible AI

Integration of AI and ML is already accelerating and changing medical device development. From enabling groundbreaking technologies to revolutionizing patient care, AI is laying the foundation for the medical devices of tomorrow. However, success in this domain requires balancing innovation with compliance, backed by robust tools that alleviate complexity.

Jama Software’s AI solutions empower organizations to tackle these challenges head-on, reducing risks, streamlining workflows, and ensuring quality at every step of medical device development.

Want to see how AI can streamline your product development?

Book your free demo today and experience the power of AI in revolutionizing requirements management for medical devices.