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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 […]
ISO 24089, developed by the International Organization for Standardization (ISO), is a standard that provides guidelines for managing software updates in a methodical and orderly way. Planning, testing, deployment, and monitoring are all included in the framework for managing the software update process that is specified by the standard. The main requirements and advantages of […]
Looking to stay ahead of ever-evolving regulations governing medical devices? In this webinar, we discuss the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they’re having on the medical device industry. Vincent Balgos, Director of Medical Device Solutions at Jama Software and Saby Agai, Sr. Consultant […]
Streamlining Defense Contract Bid Document Deliverables with Jama Connect® In the defense sector, whether it is a large prime, a subcontractor, or one of the thousands of other organizations under the defense umbrella, winning a contract bid for the United States Government comes with as astronomical amount of document deliverables that can be daunting and […]
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. […]
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 Class I Recalls Hit 15-year High in 2022” – originally […]
The Top Challenges in Industrial Manufacturing and Consumer Electronic Development From supply chain disruptions to digitization – learn more about what development teams are up against and get expert suggestions for how to overcome them PART I: The Top Challenges in Industrial Manufacturing and Consumer Electronic Development Industrial manufacturing has always been a cornerstone of […]
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 Air & Space Forces Magazine, titled “Digital Transformation of Verification Process for Faster Aircraft […]
In this webinar, “Why it Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System”, learn about the implementation of the Threat and Risk Analysis (TARA), the centerpiece of the new Automotive Cybersecurity standard ISO 21434. Many companies currently use spreadsheets to develop TARAs, which can be challenging when managing large sets […]