Links
21 CFR 820.65: [ Ссылка ]

ISO 13485:2016 § 7.5.8: [ Ссылка ]

Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 6
 Tasks 16, 18
o Chapter 7
 Task 9

Our requirement, Traceability, comes directly from 820.65 and 13485 Section 7.4.2 & 7.5.9

Traceability in 5 words: Ensure Traceability supporting Remedial Actions

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