Risk Assessment
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Use this Risk Assessment template to systematically identify, analyze, and control potential hazards associated with your medical device, as required by ISO 14971:2019. Complete this document during product development and whenever significant changes occur, to ensure that all risks—such as software, usability, and cybersecurity—are addressed, mitigated, and documented for regulatory compliance. This template is essential for demonstrating risk management and residual risk acceptability in your device’s technical documentation.