FDA guidelines on cybersecurity for medical device manufacturers are continuously evolving, creating new challenges for OEM’s and service providers alike. Andrew Garnett, Software Engineering Manager at Minnetronix, recently joined the Medical Design Briefs podcast to talk about the history and evolution of these guidelines and the regulatory landscape.
In the episode, Garnett talked about the history and iterations of the FDA cybersecurity guidance, manufacturer requirements and best practices, how device manufacturers can stay ahead of potential vulnerabilities while still meeting FDA compliance requirements, and Minnetronix’s cybersecurity plan and process. They wrapped up by covering how the FDA works with medical device manufacturers to address concerns, and available resources to help navigate the regulatory process.
You can listen to the podcast here:
Medical Design Briefs Podcast – The FDA’s Role in Medical Device Cybersecurity