RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019
ONLINE + LIVE VIRTUAL CLASSROOM TRAINING - BLENDED COURSEThis 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.
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BLENDED COURSE |
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| 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 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
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 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?
How long does it take to complete the course?
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.
After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.
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.
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!