IVDR in a nutshell – Risk Management

The relation between IVDR and ISO 14971:2019, impact on Technical Documentation and QMS

What is required to demonstrate compliance to the IVDR regarding Risk Management? How do I perform risk analysis, and estimate probability and severity? How to deal with legacy devices? This training will give you the answers!

Course description

After this half day training you will be better equipped to tackle the questions above.
We’ll walk you through the key IVDR requirements on Risk Management and provide you with tools whether you need update your existing Risk Management Files or build it “from scratch”.

To get the full understanding of IVDR requirements on Quality Management System, Risk Management and the Technical File – combine this course with:

Course outline

  • Risk Management (RM)– how to manage legacy products and integrate risk management in a design & development project.
  • How to define hazards, hazardous situation and corresponding harms for IVD products.
  • Reducing risk “as far as possible” – correlation to standards and “state-of-the-art”.
  • How to perform the Overall Residual Risk Evaluation
  • Post-Market Surveillance, it’s relation to Risk Management, and monitoring of trends

Learning objectives

Completion of this course will give you the knowledge needed to update Risk Management File and corresponding parts of the Technical Documentation, to demonstrate compliance to IVDR and ISO14971:2019.

Who should attend

The course is suitable for persons involved in Risk Management, or Design & Development of In-Vitro Diagnostic devices, such as: Design engineers, Quality specialists/Engineers, but also QA/RA Managers.


  • You should have knowledge of basic principles ofRisk Management (=previous training in ISO 14971)
  • You should have at least 2 years of experience from the medical device industry



IndustryIVD, Medical Device

Åse Ek