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In this post, we highlight and summarize parts of the new “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.” It is important to note that this content contains non-binding guidance and therefore is not currently for implementation. With that said, while […]
In this post, we examine functional safety standards like ISO 26262 for automotive developers, and how LHP and Jama Software can help ensure compliance.
In the third installment of our 2020s Predictions series, we’re featuring medical device security predictions from Chris Gates, Principal Systems Security Architect at Velentium, a professional engineering firm specializing in the design and manufacturing of therapeutic and diagnostic active medical devices.
Despite ongoing concerns about cybersecurity, the medical device landscape has seen some amazing advances even just this year.
In this post, we offer insight into anticipated changes coming in the official update.