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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 […]
In this blog, we partially recap this customer story, “Vave Health Migrates to Jama Connect® to Accelerate Development and FDA Clearance” Read the entire story HERE. Vave Health is committed to revolutionizing the physician-patient experience through innovative, industry-transforming technologies. Their innovative handheld ultrasound device packs the ability to wirelessly connect with your Android or iOS […]
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 Spyrosoft, titled “CE marking for Medical Device Software: a step-by-step guide” – originally authored […]
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 Engadget, titled “TSMC is building a second chip plant to meet US semiconductor demand” […]