Mergers and Acquisitions in MedTech: Positioning Your Company for Success

The MedTech Mergers and Acquisitions (M&A) scene is more active than ever. As global healthcare needs grow and regulatory landscapes shift, strategic acquisitions are becoming a key route to innovation, growth, and market expansion. For emerging MedTech companies, understanding this environment and positioning themselves smartly within it can shape their future.

Recent activity shows that opportunity is abundant for companies that are prepared. Strategic buyers are on the lookout for innovative technologies, strong product pipelines, and solid regulatory foundations. But having a breakthrough product is not enough. Success in M&A hinges on preparation, documentation, and systems that can stand up to intense due diligence.

The Current M&A Landscape: A Shifting Landscape

The MedTech M&A scene has evolved dramatically over the past year, marked by fewer deals but significantly larger transactions. While deal volume dropped by over 40%, the average deal size surged to $636 million, driven by strategic acquisitions like Stryker’s $4.9B purchase of Inari Medical and Thermo Fisher’s $4.1B buyout of Solventum’s filtration business.

Strategic Focus: Bigger Bets, Sharper Targets

Major players like Johnson & Johnson and Medtronic continue to lead the charge, but their strategies are shifting. J&J, for example, has spent over $30B on acquisitions since 2022, including Shockwave Medical ($13.1B) and Abiomed ($16.6B). These deals weren’t just about scale as they targeted technologies that redefine standards of care, particularly in cardiovascular intervention.

Medtronic, meanwhile, is leaning into tuck-in acquisitions to transform slower-growth units into innovation hubs. With 11+ deals in the past five years, the company is focused on strategic adjacencies and long-term portfolio optimization.

Trends Driving the Market

• Portfolio Shifts: Companies are divesting non-core assets and doubling down on high-growth areas like robotics, diabetes, and structural heart technologies.
• Private Equity’s Role: PE firms are increasingly active, both as buyers and partners in divestitures, helping streamline portfolios and unlock value.
• Cultural Fit Matters: Executives emphasize that successful deals go beyond financials. Shared values and aligned visions for patient impact are now critical to integration success.

What Strategic Buyers Seek: The Acquisition Criteria That Matter

To attract the right buyer, emerging MedTech companies need to align with what strategic acquirers value most. Here is what consistently matters:

Technology Differentiation & Market Position

Buyers want technologies that offer real clinical advantages such as better outcomes, simpler procedures, or cost savings. Proprietary tech backed by strong patents is especially attractive.

The best targets complement the buyer’s existing portfolio and address unmet clinical needs. Think AI diagnostics that plug into existing imaging platforms or minimally invasive tools that expand surgical options.

Regulatory Clarity

A clear regulatory strategy is a major plus. Companies that have engaged with the FDA, gathered solid clinical data, and understand approval pathways stand out.

Detailed documentation like pre-submission notes, trial protocols, and quality systems reduces risk and speeds up integration. It also boosts valuation.

Commercial Potential

Buyers assess market size, competition, and go-to-market strategy. Companies with clinical relationships, distribution channels, or early traction are more appealing.

Technologies that target large markets with clear reimbursement paths, and show signs of physician adoption, are especially valuable.

Financial Performance and Scalability

Even early-stage companies need to show a viable business model. Efficient use of capital, clear milestones, and scalable operations build credibility.

Detailed financials like cost breakdowns, revenue forecasts, and funding needs help buyers model ROI and integration scenarios.

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

Getting Acquisition-Ready: Preparing for Due Diligence

Due diligence represents the most critical phase of any acquisition process. Companies that invest in comprehensive documentation and systematic organization significantly improve their chances of successful transactions and favorable valuations.

Product Documentation

Keep everything up to date: design requirements, risk files, and testing protocols. Use document control systems to manage versions and changes.

Requirements management is key. Acquirers want to see how products were developed, validated, and maintained. Full traceability from concept to release builds trust.

Risk & Quality Systems

Risk documentation such as hazard analyses, mitigation controls, and post-market surveillance plans is essential. Quality systems should be fully implemented and certified (ISO 13485 is a big plus).

Design controls should be complete and easy to navigate: planning, inputs/outputs, reviews, V&V protocols, and change logs. A well-organized design and development file makes due diligence smoother and less risky.

Testing and Validation Evidence

Strong testing documentation is essential to prove your product’s safety and performance. This includes everything from software testing protocols and biocompatibility studies to electrical safety tests and clinical evaluations.

To stand out, companies should maintain:

• Detailed test plans
• Clear procedures
• Organized results

This shows a systematic approach to validating product performance. When testing documentation is thorough and easy to navigate, acquirers can quickly assess technical risks and regulatory readiness.

Validation should not stop at product launch. Ongoing monitoring, post-market studies, and performance tracking signal a commitment to continuous improvement — something buyers value highly.

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

Intellectual Property and Regulatory Assets

Your IP and regulatory documentation are more than just paperwork — they are strategic assets. Patent portfolios, FDA submissions, and clinical data all play a key role in valuation and deal structure.

To prepare:

• Keep patent files current
• Document freedom-to-operate analyses
• Develop a clear IP strategy

On the regulatory side, maintain organized records of:

• FDA correspondence
• Clinical trial data
• Post-market surveillance reports

Well-managed documentation shows a strong compliance history and gives acquirers confidence in your ability to navigate future regulatory hurdles.

How Jama Connect^® Supports M&A Readiness

Requirements management and traceability are critical for M&A success and that’s where Jama Connect shines.

The platform helps companies maintain acquisition-ready documentation throughout the product lifecycle by:

• Connecting requirements to design decisions, tests, and regulatory submissions — giving acquirers full visibility into development processes.
• Organizing documents with version control — making it easy for due diligence teams to trace product history and compliance.
• Generating detailed reports — showcasing the maturity of your quality management system and development discipline.
• Supporting collaboration across teams and locations — ensuring documentation integrity even in distributed environments.

With Jama Connect, medical device and life sciences companies can confidently present their development story and proof of compliance, a major advantage during acquisition discussions.

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

Building Long-Term Value Through Strategic Preparation

The MedTech M&A landscape is evolving fast. As healthcare needs grow and technologies advance, new opportunities are emerging for companies that are ready.

Success isn’t just about having a great product. It’s about:

• Operational excellence
• Regulatory sophistication
• Systematic development processes

Investing early in documentation, requirements management, and quality systems pays off. These capabilities lead to faster development, lower regulatory risk, and better product quality.

If you’re looking to strengthen your M&A readiness, start by evaluating your documentation systems. Book a demo with Jama Software to see how structured requirements management can streamline your development and boost acquisition appeal.

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

How to Master Traceability in Medical Device Development

As an engineer in the medical device industry, you’re tasked with creating innovative products that are both safe and effective. However, this core mission is often overshadowed by the immense pressure of regulatory compliance and documentation. As technology advances and products get more complex, that task gets even more complicated. Managing traceability between thousands of requirements, risk items, and test activities can feel like a “paperwork” burden that pulls you away from what you’d rather be doing: designing and testing new products.

This article offers a practical guide to transform traceability from a time-consuming chore into a strategic advantage. We’ll explore how to build a robust traceability model that not only satisfies regulators but also helps you build better, safer products faster.

TL;DR: Stop treating traceability as an end-of-project scramble. By implementing a single source of truth with Live Traceability™, you can connect requirements, risks, and tests in real-time. A modern platform like Jama Connect^® automates this process, helping you identify gaps early, reduce rework, and free up your team for more efficient product development.

The High Cost of Inefficient Traceability

When traceability is managed with disconnected documents and spreadsheets, it becomes a significant bottleneck. This manual approach is not just inefficient; it introduces substantial risks that can derail a project and kill the team’s morale. For complex medical devices, the consequences of poor traceability are severe:

• Project Delays: Manually creating and updating traceability matrices consumes hundreds of hours, often at the end of a project that results in pushing back launch dates.
• Compliance Risks: Incomplete or inaccurate traceability is a common reason for audit findings and can jeopardize FDA submissions and technical file reviews under the EU MDR.
• Increased Rework: Without a clear line of sight between requirements and tests, design changes can have unforeseen impacts, leading to costly rework late in the development cycle.
• Reduced Innovation: Engineers spend valuable time on administrative tasks instead of focusing on design, testing, and innovation.

The key takeaway: Treating traceability as a final-step documentation exercise is a high-risk strategy. The true cost isn’t just the time spent on paperwork, but the project delays, compliance failures, and missed opportunities that result from it. You can assess your own risk by taking a Requirements Traceability Diagnostic.

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

How-To: Best Practices for Ensuring Medical Device Traceability

To move from a reactive to a proactive approach, you need to integrate traceability into the fabric of your development process. Here are four actionable steps to make that happen.

Step 1: Establish a Single Source of Truth

The foundation of effective traceability is a centralized platform where all product development data resides. When requirements, risk analysis, and test cases live in a single system, you eliminate the confusion and errors caused by separate documents.

A single source of truth ensures that every team member—from systems engineering to quality assurance—is working with the most current and approved information.

• Benefit: Creates consistency and provides a complete, auditable record of your design history.
• Impact: Reduces miscommunication and errors, ensuring all teams are aligned.

Step 2: Implement Live Traceability™

A static, manually created traceability matrix is outdated the moment it’s finished. Live Traceability, in contrast, creates a dynamic, real-time map connecting every requirement to its corresponding risks and test cases.

With Live Traceability, you gain instant visibility into the health of your project. If a requirement changes, you can immediately perform an impact analysis to see which downstream requirements, risk mitigations, and test items are affected.

• Benefit: Allows you to identify and address gaps in coverage early in the process.
• Impact: Drastically reduces audit preparation time and minimizes the risk of missing critical connections.

Step 3: Integrate Risk Management into Your Workflow

For medical devices, traceability isn’t just about connecting requirements to tests; it’s about proving that every potential hazard has been identified, analyzed, and mitigated. This is a core expectation of standards like ISO 14971.

By managing risk within the same platform as your requirements, you can directly link risk control measures to the design requirements that implement them. This creates a closed-loop process that demonstrates comprehensive risk management.

• Benefit: Ensures product safety is a continuous focus that woven into all project milestones, not a separate, check-box activity.
• Impact: Builds a safer, more reliable product and provides clear evidence of compliance for regulators.

Step 4: Streamline Collaborative Reviews and Approvals

Formal design reviews are a critical part of the development process, but they can be slowed down by manual feedback cycles via email or comments in disjointed documents. A modern platform streamlines this with a dedicated review center.

This allows stakeholders to comment, vote, and approve items in a structured, collaborative environment. All feedback is captured in one place, creating a clear and permanent audit trail of every decision.

• Benefit: Accelerates feedback loops and decision-making.
• Impact: Ensures that all approvals are documented and traceable, strengthening your Design and Development File.

From Burden to Benefit with Jama Connect

Implementing these best practices is far simpler with a purpose-built tool. Jama Connect is designed to help medical device teams master traceability and accelerate efficient product development.

By providing a single platform with Live Traceability, integrated risk management, and collaborative review workflows, Jama Connect helps you build your traceability matrix as you work. This transforms it from a document you create at the end of a project into a powerful, real-time tool you use throughout the project.

Customer success stories highlight the impact. For example, Dexcom achieved a 60% improvement in systems engineering efficiency by using Jama Connect to manage its complex requirements. Similarly, Vave Health significantly reduced the time spent on traceability matrices, accelerating its development and path to FDA clearance.

The most important benefit: Jama Connect empowers engineers to focus on what they do best—designing and building life-changing medical devices—by turning the “paperwork” of traceability into an automated, value-adding process.

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

FAQs: Medical Device Traceability

Q: What is a traceability matrix in medical device development?
A: A traceability matrix is a document or table that demonstrates the relationships between user needs, design inputs (requirements), design outputs (specifications), risk control measures, and verification and validation activities (tests). While traditionally created in spreadsheets, modern solutions like Jama Connect provide Live Traceability, which is a dynamic, real-time view of these connections, making it far more accurate and less time-consuming to manage.

Q: How does traceability help with FDA and EUMDR compliance?
A: Regulatory bodies like the FDA (under the new QMSR) and the EU (under MDR) require manufacturers to prove that their device is safe and meets all specified requirements. A complete traceability record is the primary evidence used to demonstrate this. It shows auditors that every requirement has been tested, every risk has been mitigated, and the entire development process was conducted under a state of control.

Q: Can we integrate Jama Connect with our existing engineering tools?
A: Yes. Jama Connect is designed to serve as the central hub for requirements and risk management while integrating with other best-of-breed tools in your ecosystem, such as Jira, Azure DevOps, and various testing suites. This creates a connected toolchain that provides end-to-end traceability without forcing your teams to abandon the specialized tools they rely on.

Take Control of Your Traceability Process

Stop letting manual traceability processes create bottlenecks and introduce risk. By adopting an integrated approach, you can pass audits with confidence, accelerate your time-to-market, and empower your engineers to focus on innovation.

Ready to see how you can transform your product development process? Schedule a personalized demo to learn more about Jama Connect for Medical Device Development.

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

In this blog, we preview a section of our recent customer story. To download the entire story, visit “Onera Health Chooses Jama Connect® to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story”

Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story

About Onera

Onera Health develops clinical-grade remote diagnostics and monitoring solutions, making home polysomnography broadly accessible and user-friendly for anyone who needs it, wherever they are.

Customer Story Overview

Onera Health has developed a sleep diagnostic system utilizing four patch-based sensors that patients could apply at home. Initially, the Onera STS 1 product development team conducted pilot studies and relied on Microsoft Excel and Word to manage requirements and create the necessary documentation for successful Medical Device Directive (MDD) and Food and Drug Administration (FDA) submissions.

With the development of the company’s second-generation commercial product, the Onera STS 2, and its integration into Onera’s enhanced end-to-end solution, Onera Health took an active approach in recognizing and acknowledging the increased complexity of its second product. The company began seeking a more structured procedure for managing requirements, tests, and risks.

The new solution needed to provide better access, efficiency, and collaboration for teams working in different disciplines so they could accelerate development with confidence. Onera Health chose Jama Connect because it enabled faster iterations, greater consistency of requirements after changes are made, and visibility into risks and related mitigations.

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

With Jama Connect, Users Experience:

• Faster iterations on requirements due to less time spent in alignment, review, and audit meetings
• Consistency of requirements, terminology, configurations, and documents for all teams affected by design changes
• Visibility into risk identifications and mitigations for internal and regulators’ teams

“We needed a more structured approach due to the complexity involved in maintaining consistency across our entire documentation set. With our first generation, tracking the impact of a design change or updates impacting multiple disciplines was time-consuming and came with its own challenges.” – PIETER ERMERS, FOUNDER AND VP QUALITY & REGULATORY, ONERA HEALTH

Challenges

Complexity of product design, regulations, and document strategy lacking efficiency, scalability, consistency, and accessibility.

Managing requirements and tests, while maintaining document consistency, was generally challenging due to product and regulatory complexity, as well as the limitations of an on-premises document database. Additionally, accessing the database required a VPN which can slow work or interrupt progress when the connection was down.

“We chose Jama Connect because of its intuitive user experience, cloud-based availability, and flexible output that our global team needed. Jama Software Consultants were very supportive in helping us understand how to set up Jama Connect to achieve our goals.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH

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

Evaluation

One cloud-based system, accessible and user-friendly, with integrated collaboration and reviews, automated test input, and flexible reporting.

The evaluation demonstrated that Jama Connect could easily be accessed and used to manage requirements, tests, and risk based on its intuitive user interface, authoring, collaboration, reviews, and verification. Automated input of test results and flexible output in generating reports provide a tailor-fit to the company’s needs.

“When making changes in a requirement used in multiple sensors, we must maintain consistency of requirements, tests, and documents across teams and disciplines. Jama Connect’s structured approach for automatically checking that everything is covered is very beneficial for us.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH

Outcomes

With Jama Connect, the Onera team has experienced the following benefits:

• Faster iteration on requirements due to less time spent in alignment, review, and audit meetings
• Consistency of requirements, terminology, configurations, and documents for all teams affected by design changes
• Visibility into risk identifications and mitigations for internal and regulators’ teams

Learn how Jama Connect helps medical device companies succeed with higher quality and faster time to market.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development

In this blog, we recap our recent customer story, “Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect” – Click HERE to download it in its entirety!

Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect^®

Centralized requirements, Live Traceability™, and enhanced collaboration power Dexcom’s development of life-changing CGM technology.

About Dexcom:

• Develops, manufactures, produces, and distributes Continuous Glucose Monitoring (CGM) systems for diabetes management
• Headquartered in San Diego, California, USA

Dexcom was founded in 1999 to make diabetes management better with the world’s first real-time, integrated CGM system, the Short-Term Sensor (STS). This, and subsequent generations of the device now named the G series, combines hardware, software, and firmware to deliver an optimal user experience for making decisions about insulin and food intake.

After most of its history as a single product company, Dexcom developed Stelo, a wearable glucose biosensor available over-the-counter for people with type 2 diabetes who don’t require insulin.

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

CHALLENGES

• Siloed Tooling: A document-centric approach and legacy tools created barriers to adoption and collaboration across engineering disciplines.
• Traceability Gaps: Lack of a unified view of traceability made change management complex and created confusion across teams.
• Regulatory Overhead: Manual processes for generating regulatory document templates caused significant delays and administrative burden.
• System Complexity: Managing a complex set of interconnected hardware, software, and embedded requirements lacked a single source of truth.
• Disconnected Ecosystem: Poor connectivity between requirements management and other engineering tools hindered end-to-end visibility.

Dexcom’s products combine software, hardware, and firmware, each with their own requirements and tests that must be managed and traced for compliance. As the company scaled, the existing processes, which relied on a mix of legacy tools, spreadsheets, and documents created information silos. Teams were often uncertain if they were working with the latest requirements, leading to rework and inefficiencies.

Generating audit-ready documents for regulatory compliance was a time-consuming, manual effort. The engineering and quality organizations invested significant time in manual documentation to ensure their products were always safe, effective, and compliant.

“We have a lot of smart people who joined Dexcom with expectations about doing great things. Having them spend a significant amount of their time manually copying and pasting in spreadsheets and Word documents is not the best use of their talent and expertise,” says Sri Harsha Maramraju, Senior Manager, Systems Design Engineering at Dexcom

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

EVALUATION CRITERIA

• A central repository to keep all stakeholders informed of requirements status and changes.
• An intuitive user experience to encourage broad adoption and cross- functional collaboration.
• Full end-to-end traceability of all requirements and tests to support design controls and compliance.

Dexcom identified the need for a modern, centralized platform to manage requirements, tests, reviews, and documentation. The goal was to find a system with an intuitive interface and clear traceability to improve efficiency, stakeholder engagement, and compliance readiness. After a thorough evaluation of several leading solutions, the stakeholders selected Jama Connect. The platform’s exceptional usability, robust traceability visualization, and deep-rooted acceptance in the medical device industry made it the clear choice.

Key evaluation areas where Jama Connect excelled were its ease of use and powerful document generation capabilities. Another critical factor was its ability to provide clear visibility into the end-to-end traceability of all hardware, software, and firmware requirements and tests.

“Other tools have traceability, but only Jama Connect has a visual, configurable model that shows exactly what traceability looks like and accommodates our product’s complex configuration.” Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

For regulatory compliance, Jama Connect stood out with its out-of-the-box framework for medical device development, which simplifies alignment with stringent quality and safety standards.

“The built-in support for standards like ISO 14971 and the validated package included with Jama Connect give us the confidence to demonstrate that we are following industry best practices,” says Maramraju.

RELATED: Jama Connect for Medical Device Development

OUTCOMES

• Streamlined change management and reviews for monthly releases using Jama Connect’s Review Center.
• Achieved a 60% productivity boost for the systems engineering team, enabling faster project completion.
• Successfully migrated active projects to Jama Connect, ensuring a smooth transition to a modern platform.
• Driving reuse of requirements and tests across projects to support product line engineering (PLE) goals.

“If you’re building a centralized ecosystem for product development and design controls for the long term, you can rely on Jama Connect. Its usability, traceability, and industry-wide acceptance make it a cornerstone of our engineering process.” – Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

Dexcom now depends on Jama Connect to efficiently manage requirements, changes, and reviews for its aggressive release cadence. Having one centralized place for these activities has improved systems engineering efficiency by 60%. The intuitive collaboration and review functionality in Jama Connect has increased stakeholder engagement. Quality and Regulatory teams now actively participate in the process within the tool, appreciating the structure and auditability it provides. “The conversation has shifted. Instead of discussing tool limitations, our teams now have productive, data-driven discussions about the work itself within Jama Connect. When other departments see what we are doing, they ask how they can get their projects onto the platform too,” says Maramraju.

Jama Connect’s Live Traceability™ has enabled Dexcom to track requirements through all stages of development, with integrations that sync requirements data to development activities in other tools like Jira. Looking forward, Dexcom is leveraging Jama Connect to drive reuse and synchronization of requirements across different platforms, a key step toward their product line engineering goals.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect

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.