INTRODUCTION TO RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019 (ONLINE)
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 engineers, product specialists and the Quality Assurance department.
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.
Benefits for you
Become confident in doing risk management work
The goal is that upon completion of this course, you should be able to 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.
- What you need to know
- 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 managament
- 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
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. Final Exam
- Final Exam
14. Course Evaluation
- Course evaluation
About the instructor
Peter Sebelius (PMP) 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 too having developed, amongst other things, a mechanical chest compression 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.
to buy the course:
Frequently Asked Questions
All in all, the average time to complete the course is 6-10 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?
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.
What are the pre-requisites for this course?