Links
• 21 CFR 820.30j: www.accessdata...
• ISO 13485:2016 Section 7.3.10: www.iso.org/st...
• Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/me...
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: www.cognidox.c...
• Design History File (DHF): An Overview, QualityMedDev, Sep 16th, 2020: www.qualitymed...
• Design Control Guidance For Medical Device Manufacturers: www.fda.gov/re...
• Design Controls, Joseph Tartal: www.fda.gov/me...
• GHTF Design Control Guidance for Medical Device Manufacturers (Replaced by ISO 14969:2004): www.imdrf.org/d...
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
Негізгі бет Design History File 820.30j & ISO 13485 § 7.3.10 (Executive Series #19)
Пікірлер: 9