Risk management for medical devices and ISO 14971

Held over 2 days this course is designed to teach you to work with risk management according to the requirements of ISO 14971.

 

 

 

 

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 including Annex Z from the EN ISO 14971:2012 version of the standard as well as an orientation on the ISO 14971 risk management’s relation to tools and techniques such as FMEA, P-MEA 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 bring up if you will get 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 JWG3 that authors the standard. If you are taking a risk management course, make sure you attend a course where the instructor has first hand information.


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 programme

Day 1

  • Introduction
  • What is risk management
  • Why risk management
  • Standards relating to risk management
  • The general requirements of risk management
  • Annex Z
  • Risk analysis
  • Risk evaluation
  • Risk control

Day 2

  • Risk management tools and techniques
  • Overall residual risk evaluation
  • Risk management report
  • Production and post-production information

 

 

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.

 

Frequently asked Questions


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

For the course price, you will get the course, course material, templates , coffee and snacks throughout the day and snacks. For courses held in Hörsholm, also breakfast is included.

There is no certification or accreditation for risk management, however the instructor has documented training in the field since many years and continuously participate in authoring the ISO 14971 standard, which is the highest qualification you can have in this area.

The maximum number is 12. With more people on the course, you loose the interactivity and people won’t dare to ask questions.

Sure, I will be happy to send a proposal for a company internal version of this course to you. Use the contact form to request a proposal.

There are no pre-requisites for this course.

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.

Please request the course programme by filling out the form below to get the programme including pricing and early bird discounts when applicable.

Please request the course programme by submitting the form below. Dates and venues are found for each course in the programme. The programme also contains more detailed information on the course than this page.

Register for a course

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

Enter your details below to request more information about our professional courses in medical device product development. Or simply call us on +46 708 186 800.


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