Risk management is the operational discipline by which medical-device manufacturers ensure their products deliver clinical benefit while keeping patient harm within acceptable limits. ISO 14971:2019 is the international standard that articulates this process — one of the few standards explicitly incorporated by the FDA, EU MDR and other regulators. For professionals who design, validate, register or monitor medical devices, command of ISO 14971 is an everyday professional requirement.

This instructor-led online course builds deep operational competence in safety-risk-management principles for MedTech, through the lens of ISO 14971:2019 and its companion guidance ISO/TR 24971. Students learn to identify, evaluate, control and monitor risk across the device life cycle. The course teaches the seven phases of the ISO 14971 process (planning, analysis, estimation, evaluation, control, residual-risk evaluation, and production/post-production monitoring), the precise canonical vocabulary (harm, hazard, hazardous situation, risk, severity), and the authoring of real deliverables: a Risk Management Plan, FMEA, hazard analysis, Risk Management File and Risk Management Report. It integrates IEC 62366 usability engineering and teaches how to mine the FDA MAUDE database for adverse-event signals.