Links
• 21 CFR 820.30f: [ Ссылка ]

• ISO 13485:2016 Section 7.3.6: [ Ссылка ]

• Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 5
o Tasks 9

• 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 Verification, comes directly from 820.30f and 13485 Section 7.3.6.

Design Verification in less than 5 words:
Testing Shows Outputs meet Inputs

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