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MDR/IVDR Survey Shows Notified Bodies (NBs) Have Increased Capacity A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus. The […]
Jama Connect Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2 Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect… in under five minutes. In part two […]
Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1 Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in under five minutes. In part one […]
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 Beyond Type 1, titled “Tandem’s Mobi Approved by the FDA” – originally written by […]
Curious to learn how the Medical Device Framework in Jama Connect® can help streamline your compliance efforts and ensure your products meet necessary regulatory requirements? During this informative session, Vincent Balgos, Director of Medical Device Solutions at Jama Software® discusses the latest solution offerings for Medical Device and Life Sciences in Jama Connect, including: Updated […]
Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know As a product development team working in the medical device sector, assuring the dependability and safety of your products is crucial. FMEDA, or failure modes, effects, and diagnostic analysis, is a method frequently used to assess potential failure modes and […]
The Importance of Benefit-Risk Analysis in Medical Device Development Benefit-risk analysis is a crucial stage in the creation of medical devices. It entails evaluating the device’s possible benefits as well as drawbacks and deciding if the advantages outweigh the disadvantages. This examination aids in ensuring that medical devices are reliable, safe, and capable of being […]
What is a Trial Master File in the Medical Device Industry? A Trial Master File, also known as a TMF, is a collection of records and documentation about the creation, evaluation, and regulatory approval of a medical device. It shows the quality control procedures used in the device’s design, production, and testing to make sure […]
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 moving ahead with rulemaking on lab developed tests without waiting […]
Jama Connect® Features in Five: Using Jama Connect with a Quality Management System (QMS) for Medical Device & Life Sciences Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect®’s powerful features… in under five minutes. […]