Risk management for medical devices and ISO 14971 (online)
This online course will teach you how to work practically with risk management according to the requirements of the ISO 14971 standard. The course covers all parts of the risk management process. This includes Annex Z from the EN ISO 14971:2012 version of the standard, an orientation on ISO 14971 risk management’s relation to tools and techniques such as FMEA, P-FMEA and FTA. The course expires six months from the registration date. During this period, you can take the course any time you like. You can pause and resume another day and repeat lessons as much as you like. The course even plays on mobile devices with internet connection. The average time spent on the course is about 6-8 hours. A Course certificate with reference to the ISO 14971 standard is awarded upon completion of a final exam at the end of the course.
The course is regularly taken by regulatory bodies from all over the world for training of auditors.
Benefits for you
Become confident in doing risk management work
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.
Course certificates to prove to regulatory bodies you know your stuff
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.