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

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

HomeMedical Device Academy510(k) Tip – Make sure to include security controls as software requirements in your SRS
510(k) Tip – Be sure to include security controls in your SRS software requirements.
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If your device presents cybersecurity risks (e.g., wireless functionality), you should ensure that your software requirements (i.e., SRS) include cybersecurity controls. The new FDA eSTAR version 5.0 lists eight different controls and asks you where these controls are located in your documentation for a 510(k).

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