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Summary

You must systematically identify, analyze, control, and monitor all potential risks throughout your medical device lifecycle to ensure patient safety and regulatory compliance. Risk management establishes the foundation for safe device design by transforming potential hazards into controlled, acceptable risks through structured analysis and targeted mitigation strategies.

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Regulatory Context

Under 21 CFR Part 820.30 (Design Controls), you must implement:
  • Documented risk management processes integrated with design controls
  • Risk analysis following ISO 14971:2019 consensus standard
  • Risk control measures verified through testing and validation
  • Risk management file maintained throughout device lifecycle
  • Post-market risk monitoring with documented updates
Special attention required for:
  • Software risk management per IEC 62304 with safety classification integration
  • Cybersecurity risks requiring ongoing threat assessment and controls
  • Combination devices needing coordinated risk management across all components
  • Use-related risks per FDA Human Factors guidance and IEC 62366-1

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Overview

Risk management forms the critical safety foundation for your entire medical device development process, requiring you to proactively identify and control potential hazards before they can cause patient harm. This comprehensive approach transforms abstract safety concerns into concrete, manageable risks through systematic analysis and targeted control measures. Your Risk Management Plan establishes the strategic framework for all risk activities by defining your organizational approach, risk acceptance criteria, assessment methodologies, and team responsibilities. This foundational document transforms regulatory requirements into actionable processes that guide your team through complex safety decisions. The plan integrates risk management with design controls, quality systems, and post-market surveillance, ensuring safety considerations drive development decisions rather than being afterthoughts. Through your Risk Assessment, you systematically identify every foreseeable hazard associated with your device, analyzing how these hazards could lead to patient harm and quantifying both probability and severity. This detailed analysis covers hardware failures, software malfunctions, cybersecurity threats, use errors, environmental factors, and biological risks across your device’s complete lifecycle. The assessment provides the analytical foundation for determining which risks are acceptable and which require control measures, establishing clear traceability from hazards to harms to controls. Your Risk Management Report demonstrates successful execution of your risk management strategy by summarizing all activities, documenting control measure effectiveness, and providing final risk acceptability conclusions. This critical document proves to regulators that you have systematically addressed safety throughout development and that any residual risks are acceptable compared to clinical benefits. The interconnected nature of these risk management tasks creates a comprehensive safety net that evolves with your device development. Risk management drives design requirements by identifying needed safety features, influences verification testing by determining critical failure modes to test, and shapes clinical evaluation by establishing benefit-risk criteria. Post-market surveillance feeds back into risk management through real-world incident data, creating a continuous improvement cycle that maintains device safety throughout its commercial lifecycle. Software-containing devices require special consideration through IEC 62304 safety classification, which determines development rigor based on potential software contribution to hazardous situations. Cybersecurity risks demand ongoing assessment and control as threats evolve, while usability engineering must address use-related risks that could lead to use errors. These specialized risk areas integrate with your overall risk management approach rather than standing alone. Your risk management activities must demonstrate regulatory compliance by following recognized standards like ISO 14971, maintaining complete documentation with clear traceability, and proving that benefits outweigh residual risks. The quality of your risk management directly impacts regulatory approval timelines, post-market surveillance requirements, and long-term market success by establishing credible evidence of device safety and effective risk control.