Document and Records Management Procedure template
The QA Engineer is responsible for the implementation of this feedback management procedure. 4. REFERENCE DOCUMENTS. ISO 13485: 2016. 21 CFR 820 etc. Control of Non-Conforming Product SOP. Corrective and Preventive Action SOP. Field Safety Corrective Action (FSCA) Reporting SOP. Adverse Event Reporting SOP. Control of Records SOP. Risk Analysis ... ................
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