INTRODUCTION TO RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019 (ONLINE)

ONLINE COURSE

Learn how to be effective in medical device product development
at your own pace.

Take a look at our free short course on Risk Management:

ONLINE COURSE

Course length 6-12 hours
Course fee
(per person)
€ 299

Course description

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.

Do you want to order this course
for multiple people?

If you want to buy this course for multiple people, we recommend enquiring about out Professional Plan which offers extra features at a discounted price!

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.

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.

Course structure

0. Opening
1. Introduction
  • Welcome
  • 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
  • Severity
0. Opening
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
Do you think you will learn more from a classroom course?

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), 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 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 support@medicaldevicehq.com 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 our professional plan, 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 design control, however the instructor has conducted training in the field for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 14971. 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?

There are no pre-requisites for this course.

Testimonials

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!

Maria Nyåkern

CEO, AKRN Scientific Consulting

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!

Helen Therese Kalfjøs

Quality Manager, Luzmon Medical AS

Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

Professional Plans

You can buy our online courses one seat at a time through the shopping cart on Medical Device HQ using a credit card. If you want to be invoiced, you can request an invoice by sending an email to support@medicaldevicehq.com.

Get a discounted price with our Professional Plan if you are planning to buy 5 seats or more per year on our online courses Introduction to Risk Management for Medical Devices and ISO 14971:2019 or Introduction to Design Control for Medical Devices

With our Professional Plan, you will also receive group leader access for adding students when needed and get progress reports. Please fill in the form below, and we will aim to send you a proposal within 24 hours.

Order multiple online course seats