MedCity News October 30, 2025
The cybersecurity process is something you need to invest effort in now. Here’s some insight on conducting a security risk analysis that is impactful for the whole life of a medical device or medical device software.
The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA emphasizes the expectation that cybersecurity risks and vulnerabilities be addressed in a threat model. Cybersecurity procedures to support products from initial design to end of life must be implemented. Adequate cybersecurity protections must be addressed in the design inputs during development and not “bolted on” after development is completed.
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