Links
21 CFR 820.198: [ Ссылка ]

ISO 13485:2016 § 8.2.1 – 8.2.3: [ Ссылка ]

Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 3
 Tasks 12
o Chapter 4
 Task 1
o Annex 4

Medical Device Complaint Handling: Understanding the Basics: [ Ссылка ]

8 Problems That Can Lead to Medical Device Complaint Backlogs: [ Ссылка ]

The Fundamentals of Medical Device Complaint Handling: [ Ссылка ]

Medical Device Reporting (MDR): How to Report Medical Device Problems: [ Ссылка ]

Requirement name and location
Our requirement, Complaint Files, comes directly from 820.198 and 13485 Sections 8.2.1, 8.2.2, and 8.2.3.

Complaints in 5 words:
Capture, Document, Investigate, Report, Complaints

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