How do you address cybersecurity in your internal and supplier audit programs?

The new cybersecurity requirements that the FDA released in October 2023 certainly changed what companies need to provide in a 510(k) submission, and the latest FDA eSTAR template has a lot of specific documentation that companies need to include their 510(k).

If you want to learn more about the 510(k) requirements, please visit our webpage for the cybersecurity work instruction and webinar: https://medicaldeviceacademy.com/cybersecurity-work-instruction/

Have you considered how those new requirements might impact your internal and supplier audit programs?
1. Do you include cybersecurity questions in your internal audits?
2. Do you include cybersecurity in your supplier audits?
3. Do your supplier quality agreements address cybersecurity?
4. Do you have cybersecurity testing vendors added to your approved supplier list?
5. Is cybersecurity embedded in your post-market surveillance activities?
6. Do you have a schedule for cybersecurity retesting?

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Source by Medical Device Academy