Risk Management Plan
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Use this Risk Management Plan template to systematically document your medical device’s risk policy, acceptance criteria, and risk management activities in alignment with ISO 14971 and FDA requirements. Complete this document at the beginning of product development and update it throughout the lifecycle to ensure all risks are identified, evaluated, controlled, and monitored, supporting regulatory compliance and patient safety. This template is essential for demonstrating a structured, compliant approach to risk management and is required for regulatory submissions and audits.