Risk management is the discipline by which medical-device manufacturers demonstrate that 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 referenced by the FDA, EU MDR, Health Canada, and other regulators. For professionals who design, validate, register, or surveil medical devices, command of ISO 14971 is a daily professional requirement.

This 16-hour Professional Certificate Course is the entry point of the Aleph Risk Management for Medical Devices course track. It introduces the ISO 14971:2019 framework: the canonical vocabulary (harm, hazard, hazardous situation, risk, severity), the seven phases of the risk-management process (Planning, Analysis, Estimation, Evaluation, Control, Residual Risk Evaluation, Production and Post-Production Monitoring), the orientation to the principal hazard-identification methodologies (Preliminary Hazard Analysis, Failure Mode and Effects Analysis, Fault Tree Analysis, Hazard and Operability Study), and an orientation to IEC 62366-1 usability engineering as it integrates with risk management.

The course prepares participants for the Advanced level (`RAQ-530-A`), where the same content is exercised at applied depth — applied FMEA and FTA, applied risk-control-hierarchy decision-making, applied residual-risk evaluation with ALARP reasoning, applied IEC 62366-1 integration, applied post-market surveillance analysis using the FDA MAUDE database, and an authored Risk Management File and Risk Management Report for a chosen device. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the risk-management vocabulary the medical-device industry expects of any professional with a stake in the Risk Management File. Employers in this space include medical-device manufacturers, IVD manufacturers, consultancies serving manufacturers, and post-market surveillance teams.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.