Last reviewed: May 1, 2026
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What options do MedTech manufacturers have to bring older devices up to modern cybersecurity standards? Also, how does the FDA’s latest guidance change the process for updating legacy devices?
In this episode, Christian and Trevor break down the evolving challenges of managing cybersecurity for MedTech legacy devices. They explain how the FDA’s recent guidance updates create new pathways for handling older devices without requiring full redesigns. Together, they explore practical steps manufacturers can take - like penetration testing and postmarket monitoring - to stay compliant and proactive about security risks.
Key points:
(02:13) How the FDA defines legacy devices and why updates to older equipment pose unique challenges.
(03:47) Why simply replacing old devices isn’t realistic for many healthcare organizations.
(05:00) How encryption standards evolve and why older devices often can’t meet modern security expectations.
(06:25) The FDA’s distinction between controlled and uncontrolled risk.
(09:02) The FDA’s reduced burden pathway for legacy devices.
(11:07) Best practices for postmarket management plans.
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