What is required from your technical documentation and your Quality Management System, to become IVDR compliant and achieve CE-certificate for your Class B, C or D in-vitro diagnostic devices? When is an NB required and what do they require? How do I manage my Class A devices?
This course provides you with a full understanding of IVDR specific requirements on your Technical Documentation as well as your Quality Management System, and how to apply a risk-based approach both when preparing Technical Documentation and when designing the Quality Management System.
After this one 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 of your technical documentation and your quality system. The relationship between ISO13485:2016 and IVDR will be discussed and the IVDR 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 evidence 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 assess and update your current technical documentation and quality management system for IVDR compliance.
The course is suitable for persons involved in, or responsible for the operation or audit of a Quality Management System for in-vitro diagnostic medical devices who need to know the changes that comes with the implementation of the IVDR.
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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