Industry: Medical Device & Life Sciences

Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges

December 17, 2024 in /by

Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges Jama Software made its debut appearance at 2024 MedTech Conference in Toronto, CAN recently, and it was an inspiring experience. In addition to meeting passionate medical technology developers, learning the latest innovation trends, and establishing networking connections, I had the […]

[Webinar Recap] Key Systems Engineering Skills: Critical Thinking and Problem Framing

November 21, 2024 in /by

Key Systems Engineering Skills: Critical Thinking and Problem Framing Elevate your team’s success by exploring the role of critical thinking in a system engineering competency model. In this insightful session, Chris Unger, Retired GE Healthcare Chief Systems Engineering Officer and Principal at PracticalSE LLC, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®, […]

Expert Perspectives: A Method to Assess Benefit-Risk More Objectively for Healthcare Applications

November 20, 2024 in /by

Expert Perspectives: A Method to Assess Benefit-Risk More Objectively for Healthcare Applications Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields. In the […]

Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions

October 8, 2024 in /by

Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions Update: August 7, 2024 The revised part 820 is now titled the Quality Management System Regulation (QMSR). When referring to the rule that is currently effective, the FDA uses the term “Quality System (QS) Regulation” or “QS regulation.” Because both […]

FDA Seeks Feedback On Health Equity for Medical Devices

September 3, 2024 in /by

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from MedTech Dive, titled “FDA Seeks Feedback On Health Equity for Medical Devices” – originally […]

Unlocking Development Success: Jama Connect® vs. Word & Excel for Requirements and Traceability

August 21, 2024 in /by

Proactive and Live Traceability™ in Jama Connect® vs. Retroactive and Lagging Traceability in Excel Incremental increases in product development complexity can lead to an exponential increase in the effort required from Engineering and Research and Development teams to keep up in a document-based (Word/Excel) environment. PROBLEM Our medical device & life sciences team has thousands […]

Simplify Audit Documentation by Leveraging the Power of an Itemized Database

July 23, 2024 in , , /by

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 […]