Global Medical Device Podcast Powered By Greenlight.guru

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices because incidents have become more frequent, severe, and impactful. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, Director of Product Security at Velentium and author of Medical Device Cybersecurity for Engineers and Manufacturers.Chris has more than 30 years of experience developing and securing medical devices for device manufacturers and collaborates with regulatory and standardization agencies to present, clarify, and systemize tools, techniques, and processes that enable the creation of secure medical devices.Some of the highlights of this episode include:Although the FDA understands the importance of updating cybersecurity guidance, it should tie the documents to real standards from ISO and EU MDR, rather than only referencing consensus standards for global harmonization.To make secure medical