Risk management for medical devices and ISO 14971
Held over 2 days this course is designed to teach you work with risk management according to the requirements of ISO 14971
The course focuses on risk analysis, evaluation and risk control. The course is practical and is suitable for anyone working with risk management such as R&D Engineers, product specialists and the Quality Assurance department.
The course covers all parts of the risk Management process including Annex Z from the EN ISO 14971:2012 version of the standard as well as an orientation on the ISO 14971 risk management’s relation to tools and techniques such as FMEA, P-MEA and FTA.
Benefits for you
Become confident in doing risk management work
The course is practical. We will be doing real risk management, both in group and individually, because the goal is that you should be able to come out of the course and actually do value adding risk management work independently.
Templates to give you a head start
The course includes useful templates for risk management. You can customize or learn from them and use in your company. This can give you a head start on risk management if your company is not up and running already in this field.
Auditors will look for evidence that you are competent in risk management. You will have a nice-looking course certificate to bring up if you will get the question during an audit. Avoid the discussion with the auditor if you know risk management or not.
Get information from the source
The instructor is a member of JWG3 that authors the standard. If you are taking a risk management course, make sure you attend a course where the instructor has first hand information.
- What is risk management
- Why risk management
- Standards relating to risk management
- The general requirements of risk management
- Annex Z
- Risk analysis
- Risk evaluation
- Software safety classification
- Risk control
- Risk management tools and techniques
- Overall residual risk evaluation
- Risk management report
- Production and post-production information
Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.
Frequently asked Questions
Register for a course
If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.