INTRODUCTION TO RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019 (ONLINE)ONLINE COURSE
Learn how to be effective in risk management for medical devices during this self paced, interactive online course.
Take a look at our free short course on Risk Management:
|Course length||6-12 hours|
|Course fee (per person)||
Purchase the course access for yourself only:
This online 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 and QA engineers, product and application specialists and clinical research specialists.
The course covers an orientation of the risk management process according to the EN ISO 14971:2019 version of the standard as well as the standard’s relation to tools and techniques such as FMEA and P-FMEA.
In case you want to buy the course on someone else’s behalf:
Single seat course purchase is personal and linked to the user account and the email address of the person making the purchase.
If you wish to make the purchase for someone else, they will have to create a separate account, and go through the checkout process. If the participant does not have a suitable credit card, they may select to pay using direct bank transfer as payment method at the end of the checkout process.
Benefits for you
Become confident in doing risk management work
The goal is that upon completion of this course, you should understand the overall process of risk management and how to create safe medical devices. You should also be able to participate in performing risk analysis, risk evaluation and risk control according to ISO 14971:2019. You should also be aware of different risk management tools and techniques, such as FMEA and P-FMEA.
Self paced learning
You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.
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.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
- What you need to know
- Set your course goal completion date
- Pre-course assessment quiz
- Why risk management and what it is? – Part 1
- Why risk management and what it is? – Part 2
2. Introduction to risk management and tools and techniques
- ISO 14971 vs FMEA
3. The regulatory background for risk management
- The regulatory background for risk management
4. What is new in ISO 14971:2019
- What is new in ISO 14971:2019
5. The general requirements of risk management
- Getting to know the standard
- The risk management process
- Calling things by their right names
- Management responsibility and training
- Risk management planning and file
6. Risk Analysis - From hazard to harm
- When and how to start
- Hazard identification
- Reasonably foreseeable sequence or combination of events
- Hazardous situations and harm
- How to work
7. Risk analysis - Estimating risk
- Probability of occurrence of harm – Part 1
- Probability of occurrence of harm – Part 2
8. Risk evaluation
- Risk evaluation
9. Risk control
- Risk control option analysis – Part 1
- Risk control option analysis – Part 2
- Information for safety and disclosure of residual risk
- Risk controls and verification
- Estimating the residual risk and benefit
- Residual risk in EU
10. Overall residual risk acceptability
- Overall residual risk acceptability
11. Risk management review
- Risk management review
12. Production and post-production activities
- Production and post-production activities
13. Usability engineering
- Usability engineering
14. Final Exam
- Final Exam
15. Course Evaluation
- Course evaluation
This course is also delivered as a blended course, where we combine the best of two worlds. You start with the online course, and then attend a live virtual 1-day classroom session with more in-depth information and practice.
Frequently asked questions
Is the course a live webinar?
The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.
How long does it take to complete the course?
All in all, the average time to complete the course is 6-12 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.
How long will I have access to the course?
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 for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive 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). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!
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 My Courses and scroll down. You will find it under Your Course Certificates.
What payment methods will you accept?
You can pay using a credit card. You will receive a receipt of payment over email. Reach out to us on firstname.lastname@example.org if you would like to be invoiced instead. Please note, if you would like to be invoiced, this will take longer 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 devices.
Do you offer volume discounts?
If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.
Can a colleague and I take the course at the same time?
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.
Is the instructor accredited or certified to give this training?
There is no certification or accreditation for risk management, however the instructor has conducted training in the field for many years and continuously participates in authoring the ISO 14971 standard, which is the highest qualification you can have in this area.
What are the pre-requisites for this course?
There are no pre-requisites for this course.
The risk management course was extremely useful, I learnt a lot! Peter is an engaging communicator, very pedagogic, and with an in-depth of knowledge of ISO 14971. I will be recommending the course to colleagues and clients that need an on-line risk management course. Thank you!
I really liked the online course’s interactive format. The lessons were built up nicely and the slides were easy to understand and follow. The checkpoint questions helped a lot and to be able to repeat them and test myself again was awesome!
You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that the course access is linked to the email address, and the name you enter on checkout.
For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.
With a group purchase, when going through the checkout, you will receive group leader access which enables you to manage your group, including both adding and removing participants, and receiving progress reports and quiz reports.