Complaint Handling Procedures Bundle | ISO 13485 | FDA QMSR
The ISO 13485:2016 Complaint Handling Procedure Bundle groups together a series of ISO 13485:2016 quality system procedures related to the management of medical device complaints.
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Complaint Handling Procedure Bundle
The Complaint Handling Procedure Bundle groups together a series of procedures related to the management of medical device complaints.
Complaint Handling Procedures Overview
The Complaint Handling Procedure Bundle provides the procedures necessary to effectively log, manage, and respond to all sources of complaints.
Complaint Handling Procedure Bundle Content
The Complaint Handling Procedure Bundle includes the procedures listed below:
Complaint Handling Procedure The ISO 13485:2016 Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting and closing medical device complaints.
Complaint Trending Procedure The Complaint Trending Procedure defines the process utilized to analyze trends in complaint data, use of statistical techniques for the establishment of alert and action limits to the complaint handling process.
Remedial Action Recall Procedure The Remedial Action / Recall Procedure establishes the process for implementing remedial action for nonconforming medical device product marketed domestically and internationally
Medical Device Report (MDR) Procedure The Medical Device Report (MDR) Procedure governs the process used to submit Medical Device Reports (MDRs) to the FDA.
Vigilance Procedure The Vigilance Procedure provides instruction on classifying incidents to determine reportability and instruction on overall reporting process.
Product Hold Procedure The Product Hold Procedure controls product that has or will be distributed to customers globally by assigning a Hold or Release status to products either suspected or confirmed to be nonconforming.
Regulatory framework
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
