Risk Management Report
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Use this Risk Management Report template to document the summary and outcomes of your medical device risk management activities, demonstrating compliance with ISO 14971:2019 requirements. You should complete this report after executing your risk management plan, to confirm all identified risks have been addressed, appropriate risk control measures implemented, and the overall benefit-risk profile evaluated. This document is essential for regulatory submissions and audits, ensuring traceability and justification of risk-related decisions throughout the product lifecycle.