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Functional Safety (FuSA) Explained: The Vital Role of Standards and Compliance in Ensuring Critical Systems’ Safety Have you heard of FuSA? It stands for Functional Safety, and it is a vital part of any system that requires safety assurance. FuSA was designed to reduce the risk of physical injury or damage due to malfunctioning equipment. […]
In this webinar, we discuss exciting new features in our updated Jama Connect® for Aerospace & Defense framework. These updates include refreshed solutions for cybersecurity, the DoD Range Safety Requirements Library, and other libraries of standards. Also, Cary Bryczek, Solutions Director for Aerospace & Defense at Jama Software®, shares best practices in the Jama Connect […]
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 […]
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 EURACTIVE, titled “The AI Act’s Fine Line On Critical Infrastructure” – originally authored by […]
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 Data Science Central, titled “Revolutionizing the Supply Chain: Developments in the Warehouse Robotics Industry” […]
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 […]
As we enter 2023, Jama Software asked selected thought leaders – both internal Jama Software employees and our external partners – across various industries for the trends and events they foresee unfolding over the next year and beyond. In the final blog of this five-part series, we asked Steve Neemeh, CEO / CTO of LHP […]