ISO 14971 Medical Device Risk Management

It is for the people who build and maintain a medical device risk management file: risk management, design, R&D and software engineers, and quality and regulatory staff of device manufacturers. It also suits production and supplier-quality leads, contract manufacturers, importers and distributors, whose work feeds the file, and top management, who set the policy for risk acceptability. No prior knowledge of ISO 14971 is needed; ISO 13485 awareness helps.

It covers the scope of ISO 14971:2019 and its link with ISO 13485:2016; hazards, hazardous situations, harm and risk; the policy for risk acceptability, the plan and the risk management file; risk analysis, including intended use, foreseeable misuse, use error, software and data; risk evaluation and control in the standard's order; residual risk, benefit-risk analysis and overall residual risk; the risk management review; and production and post-production information, process risk, suppliers and change.

It is a set of short video modules, each followed by practice questions, and a final exam. The course page shows the number of modules and the approximate video runtime; allow additional time for the practice questions and the exam. With 12 months of access, you can complete it in one sitting or spread it over several sessions.

Yes. Learners who reach the 70% pass mark in the final exam receive a Sterling Academy Certificate of Completion for ISO 14971 Medical Device Risk Management. Each certificate carries a unique number and a QR code, and anyone can check it online using the certificate number and the holder's surname. It is a training certificate for the individual learner.

Yes. ISO 14971 Medical Device Risk Management is a self-paced online course made of short video modules, in English with captions. You study at your own pace during 12 months of access, and practice questions after modules help you check your understanding before the final exam. If a point is unclear, questions are answered by a Sterling consultant.

ISO 14971 Medical Device Risk Management has a list price of US$149 per learner, with a limited-time offer of US$99 per learner until 31 December 2026. Teams save 20% for 11 to 50 learners and 30% for 51 to 200; 201 or more learners are priced on request. Client administrators can track their team's progress. Prices are in US dollars, excluding taxes, and Sterling confirms final pricing and enrolment.

No. The Certificate of Completion is a training certificate: it shows that one person completed ISO 14971 Medical Device Risk Management and reached the pass mark in its final exam. It is not certification of an organisation, and Sterling does not certify organisations. Where an organisation seeks certification, for example of its ISO 13485 quality management system, which requires documented risk management, it is certified by an independent certification body after that body's own audit.