This 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.
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.
In this course you will learn how to:
Completion of this course will give you the knowledge needed to update and assess your current quality management system for MDR compliance.
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.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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