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Benefits to you

Risk Management overview

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 ISO 14971 risk management’s relation to tools and techniques such as FMEA, P-FMEA and FTA.

Course materials & certificate

Each attendee receives hand-out slides and templates to use in their project. A course certificate confirming attendee has the requisite knowledge is issued at the end of the course to every attendee who fulfills the requirements.

Be active

We pride ourselves in not making too many bullet points and having an active teaching style with lots of interactivity. The course has a learning goal and every section is followed up to ensure effective learning. You will be awake.

Course program

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.


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.

Register for a 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