Hello,
We are a software medical device manufacturer and we had an FDA inspection in September and we are going to have and ISO audit in November. I know that the ISO 13485 auditor can request to see internal audit reports, can they also see external audit reports?
Anticipating a "pushy" auditor . . .
Thank you in advance for you're assistance.
Anne
We are a software medical device manufacturer and we had an FDA inspection in September and we are going to have and ISO audit in November. I know that the ISO 13485 auditor can request to see internal audit reports, can they also see external audit reports?
Anticipating a "pushy" auditor . . .
Thank you in advance for you're assistance.
Anne
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