SOP Feedback and Complaint Management
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Use this SOP Feedback and Complaint Management template to systematically document, classify, and resolve feedback and customer complaints related to your medical device products. This template is essential for regulatory compliance, ensuring all feedback—including customer complaints, support requests, and negative product events—is properly monitored, evaluated, and recorded; it should be filled out whenever feedback is received from any source, especially after product release. Completing this SOP supports post-market surveillance, risk management, and continuous product improvement, meeting key requirements under MDR/IVDR, ISO 13485, and IEC 62304.