RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019 COURSE
PUBLIC COURSE / IN-HOUSE COURSEHeld over 2 days, this course is designed to teach you how to work with risk management according to the requirements of ISO 14971:2019 standard.
PUBLIC COURSE |
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|---|---|
| Course length | 2 days |
| Upcoming courses | Request up to date information |
| Course fee (per person) |
€ 1340
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| 90-day early bird special |
€ 1199
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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 Engineers, product specialists and the Quality Assurance department.
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, P-FMEA and FTA.
Due to the current COVID-19 situation, we are continuously evaluating when and how we can safely run classroom courses. If you are interested in attending a classroom course, please register you interest by filling out the form below.
Notify me when the next classroom course becomes available
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.
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
Day 1
- Introduction
- What is risk management
- Why risk management
- Standards relating to risk management
- The general requirements of risk management
- Risk analysis
Day 2
- Risk evaluation
- Risk control
- Risk management tools and techniques
- Overall residual risk acceptability
- Risk management review
- Production and post-production activities
Are you interested in taking this Risk Management classroom course
Click on the button to request information for this course.
Frequently asked questions
Do I get a copy of the course presentation?
Is the instructor accredited or certified to give this training?
What is the maximum number of participants?
Can we have the course as an in-house course?
Yes, you can have the course as an in-house course. Please use the contact form to request a proposal and we will get back to you right away.
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What are the pre-requisites for this course?
If I can’t attend the course 100% of the time, will I still get a certificate?
How much is the course?
The course fee is at the top of this page. For more information, please request the course programme by filling out the form.
When and where is the course held?
The date of the next course at the top of this page. For more information about the location and future courses, please request the course programme by filling out the form.
Testimonials
An extremely interesting course with lots of useful content that I will be able to use in my everyday work. I particularly liked the continuous evaluation aspect.
This was a really inspiring course, and I’ve learned loads of things that I’ll be able to use in my everyday work. I’m now confident that my risk management work will be quicker and more effective in the future.
