Links
21 CFR 820.200: [ Ссылка ]

ISO 13485:2016 § 7.5.4, 8.4: [ Ссылка ]

Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 6
 Tasks 27, 28

THIRD-PARTY SERVICING OF MEDICAL DEVICES: [ Ссылка ]

Observations from FDA’s Public Workshop on Medical Device Servicing and Remanufacturing: [ Ссылка ]

Requirement name and location
Our requirement, Servicing, comes directly from 820.200 and 13485 Section 7.5.4 & 8.4

Servicing in 5 words:
Required Medical Device Preventive Maintenance

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