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 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 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 […]
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 […]
When it comes to healthcare, the first to market usually gains 80% of the market share, making development speed one of the most crucial aspects of success – or failure. That’s why many organizations are looking at systems engineering as a way of connecting needs to solutions. In this webinar, Chris Unger of PracticalSE LLC […]
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 […]
What You Should Know About The FDA’s New Final Rule On LDTs On May 6, 2024, the U.S. Food and Drug Administration (FDA or the agency) published its highly anticipated final rule, which was formally published in the Federal Register on May 6, revising the regulatory definition of an in vitro diagnostic (IVD) product […]
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 […]
Expert Perspectives: A Deep Dive Into Risk Management and Designing for Cybersecurity & Patient Safety 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 […]
IVDR Common Errors: Navigating Notified Body Expectations Explore the notified body process and IVDR technical documentation with experts Margot Borgel, Director of IVD Global Regulatory Affairs at RQM+, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®. You will gain a thorough understanding of these topics and more: The notified body’s approach to […]
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