RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019

ONLINE + LIVE VIRTUAL CLASSROOM TRAINING - BLENDED COURSE

This is a blended (online + live virtual classroom session) course designed to teach you how to work with risk management according to the requirements of ISO 14971:2019 standard.

Risk Management for Medical Devices course overview video

BLENDED COURSE

Course length approx.
14 hours
Next classroom session
15 September
2020
Course fee (per person) € 799

Course description

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 and QA engineers, product and application specialists and clinical research specialists.

The course covers all parts of the risk management process as well as an orientation on the ISO 14971 risk management’s relation to tools and techniques such as FMEA and P-FMEA.

What is a blended course?

Our blended learning courses combine the best of two worlds. Online training is combined with virtual classroom sessions. You get to learn the theory at your own pace during the online course, prior to applying the theory into practice with the guidance of the expert instructor.

Our blended courses are split up into two parts, online training with a final exam and a classroom session. The online training is focused on learning the theory, it is self-paced and flexible and you can stop, start, and repeat as often as you want. The classroom session is interactive and focuses on applying the theory in practice.

We assess your knowledge and understanding at the start and continuously throughout the online training to provide feedback to you and verify the effectiveness of the training.

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 course is practical. We will be doing real risk management, both in group and individually, because 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.

Start right away

You can get started on the online course after registration and invoicing.

Course certification

Auditors will look for evidence that you are competent in risk management. You will have a nice-looking course certificate to present if you get asked 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 TC210 that authors the standard. This means the instructor has the very latest information and is therefore the very best person to be teaching you about risk management!

Course programme

This blended course is done in two parts: an online course with a final exam and a classroom session.

Online 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
8. Risk evaluation
  • Risk evaluation
0. Opening
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. Pre-classroom survey
  • Pre-classroom survey
14. Final Exam
  • Final Exam
15. Course Evaluation
  • Course evaluation

Classroom session

1-day live virtual instructor-led classroom session working on case studies & real-life scenarios.

Frequently asked questions

Is the course a live webinar?

The blended course comprises two parts: the online course and a live virtual classroom session.

The online course is made up of carefully scripted pre-recorded videos to maximize your learning. The live virtual classroom session is a virtual face-to-face 1-day session where you will be interacting with the instructor and course participants via Zoom. You are required to be visible on video when taking the classroom session.

Can I view the online 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.

How long does it take to complete the course?

All in all, the average time to complete the blended course is 14-20 hours. The online course takes approximately 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 live virtual classroom is a 1-day session and lasts approximately 8 hours.

Where can I find my course certificate?
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to My Courses, and scroll down. You will find it under Your course certificates.

After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.

Do you offer volume discounts?
If you buy more 3 or more seats, we do. Use the contact form to request a quote for 3 or more participants.
How long will I have access to the course?
You will have access to the online course for six months.
What is the maximum number of participants in the live virtual classroom?
The maximum number of participants for the live virtual classroom session is 8.
Can I fail the final exam?
No, you cannot fail the final exam. However, it is required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good marker on what you will get on the final exam.

If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR and you can take it again.

What are the pre-requisites for this course?
There are no pre-requisites for this course.
Is the instructor accredited or certified to provide training?
There is no certification or accreditation for risk management, however the instructor has conducted training in the field for many years and continuously participate in authoring the ISO 14971 standard, which is the highest qualification you can have in this area.
What payment methods will you accept?
After signing up on the course registration page, we will send you the invoice for the course.

Testimonials

I was surprised how much I enjoyed the course! It was challenging but I felt supported throughout the whole process and loved the hands-on approach during the classroom session to learning a new skill!
Valerie Robertson

Clinical Liaison, RemovAid AS

This was my second course with Peter and I am happy to convey that this is still the best supplier of Medical Device courses that I have ever experienced. I highly recommend the online/blended course format, top quality all the way through!

Anna Hedlund

Head R&D, Site Leader, CareDx AB

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.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming blended courses. You’ll have 24 hours to cancel your reservation in case you can’t come.

Get more info about the course