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FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare.
In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, director of product security at Velentium, about the shifting sands of medical device cybersecurity regulations for SaMD.
“Legally-backed cybersecurity requirements by a regulatory agency are necessary to ensure secure devices are entering the marketplace and hopefully replacing the insecure legacy devices.”
“This clause is going to have a huge impact on medical device manufacturers (MDMs) and I find it amazing how many MDMs are completely unaware of this.”
“An SBOM is a software bill of materials. It’s an ingredients list for your application.”
“This isn’t just one-and-done testing in your life cycle.”
“You’re going to have a lot of extra work coming your way.”
Medical Device Cybersecurity for Engineers and Manufacturers
Regulations (Submit comments to the FDA)
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
International Electrotechnical Commission (IEC)
ISO (International Organization for Standardization)
International Medical Device Regulators Forum (IMDRF)
Greenlight Guru YouTube Channel