RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019 COURSE

PUBLIC COURSE / IN-HOUSE 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.

Risk Management for Medical Devices course overview video

PUBLIC COURSE

Course length 2 days
Upcoming courses Request up to date
information
Course fee
(per person)
€ 1340
90-day early bird special
€ 1199

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.

Alternatively, we offer this course as an online + live virtual classroom course.

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?

Yes, the course material includes a course binder with hand-out slides where a majority of the presented content is included.

Is the instructor accredited or certified to give this 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 is the maximum number of participants?
The maximum number is 12. With more people on the course, you loose the interactivity and people won’t dare to ask questions.

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 straight away.

What are the pre-requisites for this course?

There are no pre-requisites for this course.
If I can’t attend the course 100% of the time, will I still get a certificate?
Yes, but only if you are present 75% or more of the course duration. You also have to be active on the course to be eligible for the 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 below.
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 below.

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. 

Johan Nordström

Engineering Manager, Bonesupport

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.

Kerstin Sternerup

Design Assurance Lead, ArjoHuntleigh 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.