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Medical Device Complaint Handling Processes - SimplerQMS
- https://www.simplerqms.com/medical-device-complaint-handling/
- 21 CFR Part 820.198 and ISO 13485:2016 (section 8.2.2) emphasize that your medical device company must have complaint procedures for properly receiving, reviewing, and evaluating all complaints. All complaints are to be processed promptly, …
Complaint Handling Process for Medical Device Manufacturers
- https://www.qualitymeddev.com/2021/03/25/complaint-handling/
The Fundamentals of Medical Device …
- https://www.complianceonline.com/resources/medical-device-complaint-handling.html
- FDA 21 CFR 820.198 and ISO 13485:2016 section 8.2.2 provides regulatory requirements about medical device complaint handling. As per the requirements, you must …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.198
- Such procedures shall ensure that: (1) All complaints are processed in a uniform and timely manner; (2) Oral complaints are documented upon receipt; and (3) …
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