Links
• 21 CFR 820.30j: [ Ссылка ]

• ISO 13485:2016 Section 7.3.10: [ Ссылка ]

• Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 5
o Tasks 1, 4, 12, & 13
o Annex 1

• Compiling a Design History File (DHF) for a med tech product, Joe Byrne: [ Ссылка ]

• Design History File (DHF): An Overview, QualityMedDev, Sep 16th, 2020: [ Ссылка ]

• Design Control Guidance For Medical Device Manufacturers: [ Ссылка ]

• Design Controls, Joseph Tartal: [ Ссылка ]

• GHTF Design Control Guidance for Medical Device Manufacturers (Replaced by ISO 14969:2004): [ Ссылка ]

Requirement name and location
Our requirement, Design History Files, comes directly from 820.30j and 13485 Section 7.3.10.

Design History Files requirements in 5 words:
Maintain Records Proving Regulatory Conformance

свернуть