RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019
BLENDED COURSE: ONLINE COURSE + LIVE VIRTUAL CLASSROOM SESSIONTake the frustration and uncertainty out of risk management, and achieve safe medical devices and regulatory compliance by learning how to do risk management with Peter Sebelius, one of the authors of the ISO 14971:2019 and member of the TC210/JWG1.
The course includes risk management according to the standard, and its relation to tools and techniques such as FMEA and P-FMEA. It covers both the EU and US requirements. You learn the theory first during the online course, and then apply that theory during the live virtual classroom session(s).
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BLENDED COURSE |
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| Course length | approx. 17-27 hours |
| Next classroom sessions |
1-2 June 2022 – FULL 6-7 September 2022
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| Course fee (per person) |
€ 899 Cancellation policy |
Course description
This course consists of two parts:
- The Introduction to Risk management for Medical Devices and ISO 14971:2019 online course
- A live virtual classroom session held by the course creator
First, you complete the popular introductory risk management online course. It covers topics such as risk analysis, risk evaluation, risk control and a short introduction to usability engineering.
You can start the online course immediately and have access to it for 6 months, but you must successfully complete the final exam prior to the classroom session. If you have already completed the online course, you can register for the classroom session only.
The unique, highly interactive live virtual classroom session is facilitated by Peter Sebelius, who is an authority in this field. During the session, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn firsthand from an industry expert.
A printed course companion is included, as well as time-saving templates on how to implement risk management effectively and efficiently.
We recommend this course to those who are new in the field, but also to professionals working with risk management, such as R&D and QA engineers, product and application specialists and clinical research specialists.
Want to know more about our blended courses? Watch the video below.
Our blended learning courses combine the best of both worlds: online training and a live virtual classroom session(s) afterwards.
The online training allows for the flexibility in the way you learn, so that you can learn in a way which suits you best. You can access it whenever and wherever you want, and you can stop, start, and repeat the lessons and quizzes as often as you would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course.
The classroom session is highly interactive and focuses on applying the theory you have learnt during the online course with the guidance of the expert instructor. There are real-life case scenarios to work through and plenty of time for discussions and questions.
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 has authored the latest versions of 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
Understand why and how to work with risk management
Risk management can be made extremely abstract if there is too much focus on the intangible requirements instead of how to actually do the work. After this course, you will understand the overall process of risk management and how to create safe medical devices.
After completion, you should be able to participate in performing risk assessment and implement risk controls. You will also be made aware of different risk management tools and techniques, such as FMEA and P-FMEA.
Get the big picture
You will get a clear overview of the risk management process according to ISO 14971:2019. Knowing where you are in the process is key to making the right further moves in risk management.
Blended learning combines the best of both worlds
You get to learn the theory at your own pace, during the online course, before applying the theory to practice with the guidance of an industry expert. You can get started on the online course right after registration and invoicing.
Course certificate
Auditors may look for evidence that you are competent in risk management. You will receive a course certificate after the successful completion of the course, which you can show the auditors if they ask.
Course structure
Online course
The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. You have the access to the online course for 6 months. It is self-paced and flexible in that you can start, stop, and repeat as much as you like. When you have finished the online course, you will be taking the final exam.
The Introduction to Risk Management for Medical Devices and ISO 14971:2019 online course consists of 16 lessons which are outlined below. .
0. Opening
Lesson 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
Lesson 2. Introduction to risk management and tools and techniques
- ISO 14971 vs FMEA
Lesson 3. The regulatory background for risk management
- The regulatory background for risk management
Lesson 4. What is new in ISO 14971:2019
- What is new in ISO 14971:2019
Lesson 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
Lesson 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
Lesson 7. Risk analysis - Estimating risk
- Probability of occurrence of harm – Part 1
- Probability of occurrence of harm – Part 2
- Severity
Lesson 8. Risk evaluation
- Risk evaluation
0. Opening
Lesson 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
Lesson 10. Overall residual risk acceptability
- Overall residual risk acceptability
Lesson 11. Risk management review
- Risk management review
Lesson 12. Production and post-production activities
- Production and post-production activities
Lesson 13. Usability engineering
- Usability engineering
Lesson 14. Final Exam
- Final Exam
Lesson 15. Course Evaluation
- Course evaluation
Lesson 16. Classroom session info, case study & more!
- Learn more in a live virtual class
- The live virtual class product
- Get your questions answered on the live virtual class
Classroom session(s)
You will attend this 1-day or 2 half-day live virtual instructor-led classroom session(s) via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course, in a relaxed environment, with the guidance of an expert instructor. There are real-life case scenarios to work through, and plenty of time for discussions and questions.
The live virtual class will cover the practical aspects of risk management, such as learning how to perform risk analysis, risk evaluation, and risk control according to ISO 14971:2019.
The maximum number of people in a classroom session is 8.
Included is a printed course companion and the following time-saving templates:
- Risk management SOP
- Risk management plan
- Hazard traceability matrix
- Risk management report
- Risk management file index
- Checklist ISO 14971:2007 to 14971:2019
Frequently asked questions
Is the course a live webinar?
The blended course consists of two parts: the online course, and a live virtual classroom session.
The online course is made up of carefully scripted pre-recorded videos in order to maximise 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 the other 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.
How long does it take to complete the course?
The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 10-20 hours to finish on average.
You do not 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, or 2 half-days, and lasts approximately for 7 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 for one person, we do. Use the contact form to request a quote for 3 or more participants. Please note, if there are more than 5 people from your organisation that should take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.
How long will I have access to the course?
You will have access to the online course for six months.
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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?
There is no pass/fail score on the exam as such, but you are 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 model of 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 if I have already completed the online course and taken the final exam?
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom session, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.
You will need to retake the final exam by 3pm CET the day before the classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom session.
What are the pre-requisites for this course?
There are no pre-requisites for this course.
Is the instructor accredited or certified to give this training?
There is no certification or accreditation for design control courses. 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 payment methods do you accept?
The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.
Testimonials
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!
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