After this 2-hour webinar you will be better equipped to tackle these questions. We’ll walk you through the key IVDR requirements and provide you with tools to establish a road map for your work towards IVDR compliance.
The requirements posed on specified roles such as importer, distributor and “legal” manufacturer will be discussed as well.
Finally, we will cover how the interrelation between performance evaluation, risk management and post-market surveillance can be demonstrated in your quality system.
Completion of this course will give you the knowledge needed to assess applicable requirements for IVDR compliance.
The course is suitable for persons involved in, or responsible for product development or regulatory/quality work concerning IVD-devices and who need to know the changes that comes with the implementation of the In Vitro Diagnostic 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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