SOP Risk Management
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Use this SOP Risk Management template to guide your systematic approach for identifying, assessing, controlling, and monitoring risks throughout the entire lifecycle of your medical device, in alignment with ISO 14971:2019 and relevant regulatory requirements. Complete this document during all key phases—from design and development to post-market production—to ensure comprehensive risk management, support product safety, and maintain regulatory compliance. This template is essential for documenting risk management files, plans, assessments, mitigation actions, and ongoing post-market risk evaluations.