SOP Change Management
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Use this SOP Change Management template to systematically document, evaluate, approve, and implement changes to released medical devices or quality management systems, ensuring ongoing regulatory compliance and product safety. Complete this template whenever you need to process product modifications, bug fixes, or organizational updates, especially when changes could impact risk management, technical documentation, or require notification to users and regulatory authorities. This process is essential for maintaining ISO 13485, EU MDR/IVDR, and FDA 21 CFR 820 compliance and should be initiated promptly upon identifying any necessary post-market changes.