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Tag: 21CFR820.198

Complaint management

Steps and Tips for Streamlining Medical Devices Complaint Process

Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485 and FDA . Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance.

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