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1Blog Post

The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

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What is Digital Health? Digital health merges digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery to make medicine more personalized and precise. Digital health is a broad category that includes: Mobile health (mHealth) Health information technology (IT) Wearable devices Telehealth Telemedicine Personalized medicine Digital health technologies use: Computing […]

2Blog Post

Top Signs Your Design Review Process Is Hurting Your Business

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Design review processes and their impact on product development. Development organizations typically have a predefined set of formal design reviews that are held throughout the development process. A design review usually includes assessing design input requirements for adequacy, assessing the adequacy of a design to fulfill design input requirements, and verification/validation-related reviews. When done correctly, […]

3Blog Post

[Webinar Recap] Optimizing Your QA Process by Integrating TestRail and Jama Connect®

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In this post, we recap a recent webinar hosted by Jama Software on the topic of integrating TestRail and Jama Connect As the digital demands of the business continue to escalate, software delivery teams are under extraordinary pressure to deliver more work faster. Speed, however, counts for little if these teams are not delivering a […]

4Blog Post

Lessons Learned: Medical Device Development Through COVID-19 and Beyond

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Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s Chief Product Officer. In the fall, I wrote about how the medical technology industry has struggled to keep pace with other, similar industries. In the piece, I discuss how important it is […]

5Blog Post

Simplify Audit Documentation by Leveraging the Power of an Itemized Database

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Simplify Audit Documentation by Leveraging the Power of an Itemized Database How to enhance efficiency, auditability, and stay ahead of the competition with Jama Connect® for Medical Device Development In the current landscape of medical device and life sciences development — in addition to facing relentless pressures to innovate, remain competitive, and release quality products […]

6Blog Post

2022 Engineering Predictions: Overcoming Three Key Industry Challenges

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In many ways 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will offer unique challenges, opportunities, and more than likely, many surprises.   As we enter a new year of further […]

8Blog Post

A Nod To MOSA: Deeper Documenting of Architectures May Have Prevented Proposal Loss

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A Nod To MOSA: Deeper Documenting of Architectures May Have Prevented Proposal Loss Lockheed loses contract award protest in part due to insufficient Modular Open Systems Approach (MOSA) documentation. On April 6th the GAO handed down a denial to Sikorsky-Boeing proposal protest of the Army tiltrotor award to Textron Bell team. This program is called […]

9Blog Post

Notable Changes in the New FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions

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Notable Changes in the new FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions The FDA released its new draft guidance for the Content of Premarket Submissions for Device Software Functions on November 4, 2021. Once approved, this guidance will replace the preexisting Guidance for the Content of Premarket Submissions for Software […]