RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019 COURSE
Held 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.
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.
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!
About the instructor
Peter Sebelius (PMP) 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 too having developed, amongst other things, a mechanical chest compression 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.
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.
A lively, interesting learning experience with a great mixture of high level and detail. I’m sure the course will improve our performance and save us time. Highly recommended!
Course Program
- Introduction
- What is risk management
- Why risk management
- Standards relating to risk management
- The general requirements of risk management
- Risk analysis
- Risk evaluation
- Risk control
- Risk management tools and techniques
- Overall residual risk acceptability
- Risk management review
- Production and post-production activities
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.
If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.
Get more info about the course
Course Category
PUBLIC COURSE / IN-HOUSE COURSE
Frequently Asked Questions
Do I get a copy of the course presentation?
Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.
Are you accredited or certified to give this training?
What are the pre-requisites for this course?