510(k) Tip – Be sure to include security controls as software requirements in your SRS

510(k) Tip – Be sure to include security controls as software requirements in your SRS

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Medical Device Academy • Available on Youtube • Published 8 months ago
510(k) Tip – Be sure to include security controls as software requirements in your SRS
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If your device has cybersecurity risks (e.g., wireless functionality), make sure your software requirements (e.g., SRS) include cybersecurity controls. The new version 5.0 of the FDA eSTAR lists eight different controls and asks you where to find these controls in your documentation for a 510(k).

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