Latest / The Med Device Cyber Podcast
Essential Software Documentation for Med Device Manufacturers
What documents should engineers prepare to get ready for submitting a medical device to the FDA?
In this episode, Christian and Trevor dig into the underestimated role software documentation plays in cybersecurity, especially in the medical device space. They highlight how incomplete or contextless documentation can hinder everything from SBOM utility to regulatory compliance. With sharp insights and real-world examples, they make the case for elevating documentation as a strategic priority.
Key points:
(00:43) The Real Purpose of Documentation
* Software documentation is often seen as a…
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