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Hi. I've stepped into getting my (new) company prepared for an upcoming ISO 13485 audit. We also need to meet the MDD and have a Technical File. In our ISO pre-audit, there were non-conformances for the existence and adequacy of validation reports.
Is there a required or suggested format that these should take? I've seen the link to clinivation for the validation master plan, but am wondering if there is a format for the specific validation plan itself, and what the auditors will be looking for.
Thanks!
Is there a required or suggested format that these should take? I've seen the link to clinivation for the validation master plan, but am wondering if there is a format for the specific validation plan itself, and what the auditors will be looking for.
Thanks!