Open Training: Fundamentals of the IVDR

June 04, 2018 / Europe

Date: 4 June 2018

Duration: 1 Day

Location: Amsterdam Area

Subscription:  On request


Introduction: 

The IVD Directive came into force in 1998. The world was much different then. The IVD’s regulatory framework is based on lists of products, which makes it difficult to cope with new products that do not fit into the lists.  

All new innovations make a very good case for an IVD Regulation that serves the patient well today and that can adapt to changes in knowledge and technology going forward.

Learning Objectives:

The new structure and revised scope of the IVDR

New classification rules

How to determine the conformity route

Technical documentation changes

Post Market surveillance

Supply chain requirements

Please check here for the IVDR training on 25 September 2018

Profile:

Gert W. Bos
Post date: March 08, 2018
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