Links
21 CFR 820.70c: [ Ссылка ]
ISO 13485:2016 § 6.3, 6.4.1, 7.1: [ Ссылка ]
Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 6
Tasks 4, 5, 6
Development Medical Device Environmental Monitoring Programs, by Steven G. Richter: [ Ссылка ]
Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products, By Melissa Stappen and Stephen E. Langille: [ Ссылка ]
Requirement name and location
Our requirement, Environment, comes directly from 820.70c and 13485 Section 6.3, 6.4.1, and 7.1.
Environment requirements in 5 words:
Control Environment Ensure Product Quality
