This Risk Management Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines the systematic process for identifying, evaluating, controlling, and monitoring risks throughout the product lifecycle. Ensures regulatory‑compliant risk documentation and traceability. Digital delivery within 24 business hours.
This procedure outlines requirements for risk analysis, risk evaluation, risk control measures, residual risk assessment, and ongoing risk monitoring. It includes hazard identification, risk matrices, benefit‑risk evaluation, and maintenance of the Risk Management File. Associated documents available for separate purchase include the Risk Management Plan, the Risk Analysis & Management Report, and the Risk‑Benefit Assessment, providing full support for complete regulatory compliance. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.