IVDR in a nutshell – the Quality Management System

Which elements need to be covered by your Quality Management System, to achieve CE-certification for in-vitro diagnostic devices?   What is the responsibility of the PRRC, in relation to the QMS? What will the NB need look for when auditing our Quality Management System?

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 your Quality Management System and provide you with tools to perform a gap analysis and perform an update of your quality management system, to ensure compliance with the IVDR. The relationship between ISO13485:2016 and IVDR, and the role & responsibilities of the PRRC will be clarified.

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

Course outline

  • Understand the impact of IVDR to your quality management system
  • Responsibilities of the PRRC – Person Responsible for Regulatory Compliance
  • How to utilize ISO13485:2016 to ensure compliance to the regulation.
  • How to audit your internal quality management system against IVDR

Learning objectives

Completion of this course will give you the knowledge needed to assess and update your current quality management system for IVDR compliance, make use of ISO13485:2016 to manage key regulatory requirements and apply a risk-based approach.

Who should attend

Quality Managers, Quality Specialists/ Engineers, RA Managers/Specialists, Management team members, the  PRRC (Person Responsible for Regulatory Compliance), the Management Representative, of an IVD Manufacturer.


  • You should have knowledge of medical device quality systems from working with IVDD and/or ISO 13485.
  • You should have at least 2 years of experience from the medical device industry.


Date & Time
October 31, 2022
13.00-17.00 CET
IndustryIVD, Medical Device


No. persons
3 persons or more 15% if registered and invoiced together for the same course.

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Åse Ek



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