Links
• 21 CFR 820.30i: [ Ссылка ]
• ISO 13485:2016 Section 7.3.9: [ Ссылка ]
• Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 2
o Task 3
o Chapter 3
o Task 6
o Chapter 5
o Tasks 13 & 15
o Annex 4
• Design Changes: Examples and Requirements, Prof. Dr. Christian Johner, Mar 24th, 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 Change, comes directly from 820.30i and 13485 Section 7.3.9.
Design Change requirements in 5 words:
Control Change Ensure Safe Devices
