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The 12 mandatory documents required to implement and document a complete ISO 14971:2019 risk management process for medical devices.

ISO 14971 Risk Management - 12 Mandatory Docs Kit

IEC 62304 Medical Device Software - Jump-start your regulatory documentation with this curated set of IEC 62304-aligned templates. Includes safety classification, requirements, traceability matrix, and test planning — ready to duplicate and tailor to your device.

IEC 62304 Medical Device Software Sample Pack

ISO 13485 Medical Device QM - Build your medical device quality management system from a solid foundation. Includes QMS overview, document control, CAPA, and audit templates — ISO 13485 aligned and ready to tailor.

ISO 13485 Medical Device QMS Sample Pack

ISO 14971 Medical Device Risk Management Free Sample Pack - Tackle risk management with clear, structured templates. Includes risk management plan, hazard analysis, FMEA, and risk report — ISO 14971 aligned and ready to edit.

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