Hardware Podcasts

The Future of Cybersecurity

Global Medical Device Podcast · 30 Apr 2022 · 40m · Episode 257

What this episode covers

Chris Gates, Director of Product Security at Velentium and author of 'Medical Device Cybersecurity for Engineers and Manufacturers', discusses the evolving landscape of software as a medical device (SaMD) security. He critiques the FDA's recent draft guidance for lacking harmonization with global standards like ISO and EU MDR, arguing that it imposes excessive burdens without clear, workable requirements. Gates emphasizes the critical need for machine-readable Software Bill of Materials (SBOMs) and Vulnerability Exposure (VEX) documents to help Health Delivery Organizations (HDOs) manage risks effectively. He advocates for integrating cybersecurity into the core development process, using tools like MedCrip and Heimdal, to streamline regulatory approval and create a competitive advantage for manufacturers.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Velentium
Products
Medical Device Cybersecurity for Engineers and Manufacturers
Also
FDA, ISO, EU MDR, PATCH Act, SBOM, VEX, CycloneDX, SPDX, MedCrip, Heimdal, CISA, NIST

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