MDR Audit Readiness

– how to determine if your Quality Management System is MDR compliant

This online-course provides you with a full understanding of MDR specific requirements on your Quality Management System, including an exhaustive review of the differences and similarities between ISO13485:2016 and the MDR QMS requirements.

Course description

  • Which parts of my 13485 certified-quality system need to be updated and how?
  • How do I establish an efficient feedback loop between Risk management, Clinical evaluation and Post-Market Surveillance without creating “document overload”?
  • As legal manufacturer, am I responsible to inform distributors about their new responsibilities?
  • What is my responsibility as subcontractor/contract manufacturer towards a legal manufacturer?
  • As there is currently no MDR-harmonized standards, how do we proceed in the meantime?

After this one day course you will be better equipped to tackle the questions above. We’ll walk you through the key MDR requirements on the Medical Device quality management systems and provide you with tools to perform an efficient MDR gap analysis of your quality system. The relationship between ISO13485:2016 and MDR will be discussed and the MDR requirements that are not covered by the standard pointed out.

The requirements posed on specified roles such as authorized representative, importer, distributor and “legal” manufacturer will be discussed as well as how to define and document relationships to other parties, i.e. AR, subcontractors, suppliers and between an OBL manufacturer and the OEM.

Finally, we will cover how the interrelation between clinical evaluation, risk management and post-market surveillance can be demonstrated in your quality system.

Course outline

In this course you will learn how to:

  • Identify MDR QMS requirements not covered by ISO13485:2016 and how implement them
  • Understand aspects of ISO13485 that are crucial to fulfil implicit MDR QMS requirements.
  • Be fully equipped to audit your internal quality management system against MDR.

Learning objectives

Completion of this course will give you the knowledge needed to update and assess your current quality management system for MDR compliance.

Who should attend

The course is suitable for persons involved in, or responsible for the operation or audit of a Quality Management System for medical devices who need to know the changes that comes with the implementation of the Medical Device Regulation.


  • You should have good knowledge of medical device quality system from working with MDD or ISO13485.
  • You should have at least 2 years of experience from the medical device industry.



IndustryMedical Device

Anna Sahlholm

Åse Ek