Risk management for medical devices and ISO 14971 (online)

Course information

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.



Frequently asked Questions

The course is not a webinar, but a pre-recorded course with animations and audio. You can watch it as many times as you like, whenever you want and where ever you want. You can not download the course though, thus you will need to have internet connection to take the course.

All in all, the average time to complete the course is 6-8 hours, but you can complete it in less time if you only go through it without repetitions and just one attempt at the quizzes. Please note, you don’t have to watch the whole course at once. In fact you can pause, resume and replay as often as you like. The only limitation is in the final exam, where you will only have one shot.

You have access for six months.

You need to have contact with our servers to register your result on the final exam. In the unfortunate event you have a computer problem that does not allow you to send the result of the final exam to our servers for any reason, we recommend you to capture the screen with your result using “Print screen” or any other screen capture. You can even photograph the screen. E-mail this image to us and we will investigate if you can have a course certificate even though the result has not been registered, or if you have to do the final exam again.

There is no pass/fail on the final exam (as long as you complete it within the time frame), but your result will be printed on the course certificate, so if you have between 90% and 100% correct answers, you can be proud of your result.

The course certificate is available for download after completing the final exam. Log in to your account, go to the lessons overview and expand the final exam. From there you can download a pdf version of your course certificate.

You can pay using Visa, Mastercard, Discover or American Express through paypal or use a paypal account. For Swedish and Danish customers we also offer the possibility to invoice the course. Contact us and say that you want to order the course and have it invoiced using the contact form.

Yes you can. The course is in HTML5 format which will play on any new iOS, Android or Windows phone.

If you buy more than 10 seats, we do. Use the contact form to request a quote for more than 10 participants.

The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the course.

There is no certification or accreditation for risk management, however the instructor has documented training in the field since many years and continuously participate in authoring the ISO 14971 standard, which is the highest qualification you can have in this area.

There are no pre-requisites for this course.