Links
21 CFR 820.70b: [ Ссылка ]

ISO 13485:2016 § 4.1.4, 4.2.4, 7.3.9, 7.4.3, 7.5.6: [ Ссылка ]

Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 1
 Tasks 1, 8, 11
o Chapter 2
 Task 3
o Chapter 3
 Task 6, 7
o Chapter 5
 Tasks 7, 9, 13, 15
o Chapter 6
 Task 4, 8, 21
o Chapter 7
 Task 1, 10
o Annex 4

Requirement name and location
Our requirement, Process Changes, comes directly from 820.70b and five difference sections 13485. They are: 4.1.4, 4.2.4, 7.3.9, 7.4.3, & 7.5.6.

Process Changes in 5 words:
Control Changes Ensure Safe Devices

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