RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971 (ONLINE)
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-FMEA and FTA.
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.
2. The general requirements of risk management
3. Risk analysis
5. Risk control
6. Overall residual risk evaluation, risk management report and production and post production information
7. Annex Z – The Content Deviations
8. Final exam preparation
to buy the course:
Frequently Asked Questions
All in all, the average time to complete the course is 6-8 hours, but you can complete it in less time if you don’t repeat any of the lessons and have 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 the final exam, where you will only have one shot.
You will have access to the course for six months.
What if I lose internet connection during the final exam?
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 have successfully completed the exam and therefore should recieve a course certificate even though the result has not been registered, or if you have to do the final exam again.
Can I fail the final exam?
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.
Where can I find my course certificate?
The course certificate is available for download after completing the final exam. All you need to do is 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.
What payment methods will you accept?
You can pay using Visa, Mastercard or American Express. We can send you an invoice for the course if you wish. If this is the case, please go to the course registration page. Upon registration please inform us that you would like to be invoiced for the course. It will take longer to invoice for the course and you will incur an invoicing fee.
Can I view the course on a mobile device?
Yes you can. The course is in HTML5 format which will play on any new iOS, Android or Windows phone.
Do you offer volume discounts?
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. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.
What are the pre-requisites for this course?