Risk management for medical devices: ISO 14971:2019 in practice

The risk management process from the plan to post-production: the concepts people mix up, analysis techniques, estimation and evaluation, risk control,…

This course is for quality, regulatory, R&D and clinical people who build, maintain or review a risk management file, and for start-up teams doing it for the first time. It follows ISO 14971:2019 from management responsibility and the plan, through hazard identification, analysis techniques, estimation, evaluation and risk control, to residual risk, benefit-risk, the risk management report and the information that comes back from production and the market. It grew out of my series of articles on risk management. Each lesson is a few short slides, an explanation under each slide and a check question, and every module shows what the EU MDR, the FDA and MDSAP expect. The course ends with a final test and a certificate of completion with a link anyone can use to verify it.

This course is for people who manage or contribute to the risk management of medical devices, including QA/RA managers, R&D and systems engineers, and the people who own the risk management file. It also suits project managers and clinical staff who take part in risk reviews and want to understand the whole process.

Use the core concepts of ISO 14971 correctly, and set risk acceptability criteria and management responsibility. Write a risk management plan and keep a risk management file that holds together. Define intended use and foreseeable misuse, and identify hazards and hazardous situations. Choose analysis techniques that fit the device, including for software and cybersecurity. Estimate and evaluate risks without the common pitfalls of the risk matrix. Choose and verify risk controls in the right order, and handle residual risk and benefit-risk. Feed production and post-production information back into the risk management file.