Audit checklist for "Design Controls" per ISO 13485 wanted

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Coury Ferguson

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My suggestion is to look at it as the entire process. No need for the checklist in my opinion. Audit the process "Design Controls."

Follow it through the Preliminary review, Critical review, Customer review (if required) Final review, Release, and so on, following the organization's procedures. Take good notes and document any findings.

Just my opinion.
 
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