Risk Management Videos

Total duration: 113 minutes.

Introductory Course

230 – Risk Management

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Basic Courses

The 8 videos below provide a practical overview of the Health Risk Management process. The videos advocate a Risk Management process that is compliant with ISO 14971:2019 but also includes best practice recommendations that are not explicitly required by the standard. Risk Management Subject Matter Experts and Process Owners should thoroughly read ISO 14971:2019 to fully understand all of the Risk Management options and trade-offs available to medical device manufacturers.

360 – Health Risk Management

365 – Risk Management Plan

370 – Risk Analysis Part I: Hazard Effects

372 – Risk Analysis Part II: Hazard Causes

375 – Risk Evaluation

380 – Risk Control

385 – Overall Residual Risk Evaluation

390 – Production and Post-Production Monitoring

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