The purpose of this complaint handling procedure is to define the requirements for documenting product complaints and investigations.
Customer Feedback and Complaint Handling Procedure
The purpose of this four-page procedure is to define your company’s requirements for gathering customer feedback, documenting product complaints, and complaint investigations. The procedure was last updated in 2021 for compliance with the European device regulations (i.e., Regulation 2017/745). The procedure is also compliant with FDA regulation 21 CFR 820.198 and the applicable sections of the Canadian Medical Devices Regulation (CMDR). This is the primary document meeting the applicable regulatory requirements for gathering customer feedback and complaint handling as defined in your company’s Quality System Manual (POL-001).
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What is included with this procedure?
The complaint handling procedure includes the following documents:
- SYS-018 A D2 Customer Feedback and Complaint Handling (Procedure in Word format)
- LST-011 A D1 Complaint Register (i.e., Complaint Log in Excel format)
- FRM-020 A D2 Complaint Record (Form in Word format)
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