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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 […]
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 […]
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 […]
Common Pitfalls in Change Control Traceability and How to Compensate Intro Change is constant, especially in the medical device lifecycle. These changes can be initiated by a manufacturer voluntarily, such as exchanging a component to decrease overall COGS or improve reliability. Or occur involuntarily, like when a supplier discontinues a component or regulations are revised. […]
Jama Connect® for Robotics Jama Connect® for Robotics provides a single platform for development teams to manage requirements, test, and functional safety throughout the product development lifecycle in the robotics industry. The Jama Connect Robotics Solution is a complete set of frameworks, example projects, and procedural, export, and configuration documentation intended to accelerate the implementation […]
In this blog, we’ll break down key elements of our Jama Connect for Automotive Solution. To read the entire solution overview, click HERE. Jama Connect® for Automotive Accelerate requirements management for safety- and cybersecurity-critical systems Jama Connect® for Automotive provides a single platform for development teams to build safety-critical and cybersecurity-critical products, while accelerating time […]
What is the Department of Energy National Cyber-Informed Engineering Strategy (CIE) Framework? Cybersecurity incidents have become significant in recent years, causing ripple effects across countries and communities. Regulating cybersecurity has often fallen to private entities. However, with recent cyberattacks causing large-scale impacts, government agencies are now setting forth new actions and regulations. The US Department […]