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Digital Transformation and the Importance of Requirements Management Within the DoD Looking back on a technology career that started nearly 45 years ago gives me an opportunity to reflect on the evolution of technology trends. Most notably, for me, the usability and interfaces to that technology. Let me explain… I started out as a young […]
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 […]
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 […]
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 […]
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 […]
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 […]
Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part 2 In our previous blog post, we reviewed the top things to know about software validation and computer software assurance in the medical device industry. In this installment, we’ll take a closer look at computer software validation and […]
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 “Medtech industry relieved as Europe’s MDR extension nears final approval” […]