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. […]
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 […]
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” […]
Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I Intro This is Part 1 of a 2-part series on software validation and computer software assurance in the medical device industry. While it is clear that software validation is required by regulation in the US and elsewhere […]
Your Guide to the Verifying Accurate Leading-edge IVCT Development (VALID) Act For more than four years, members of both houses of Congress have solicited input from a variety of stakeholders to improve Food and Drug Administration (FDA) oversight of Laboratory-Developed Tests (LDTs). The result is the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a bi-partisan and […]
In this blog, we recap our eBook, “An Introduction to Research Use Only (RUO)” – Click HERE to download the entire publication. An Introduction to Research Use Only (RUO) Learn how it differs from adjacent labels, the FDA and EU guidance, its appropriate use, and the consequences of mislabeling products RUO. Introduction In the complex […]
In this blog, we’ll recap our whitepaper, “Understanding Integrated Risk Management for Medical Devices” – To read the entire paper, click HERE. Understanding Integrated Risk Management for Medical Devices Knowledge on best practices, how to integrate risk-based thinking into product development cycles, and the importance of having end-to-end traceability to improve risk management, shared by […]
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