Links
• 21 CFR 820.30g: [ Ссылка ]
• ISO 13485:2016 Section 7.3.7: [ Ссылка ]
• Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 5
o Tasks 9, 10, & 11
o Annex 4
• Design Verification and Design Validation: What's the Difference?, Greg Jung, Sep 11th, 2015: [ 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 Validation, comes directly from 820.30g and 13485 Section 7.3.7.
Design Validation requirements in 5 words:
User Testing Confirming Intended Use
