IVDR - From Fundamentals to Technical Documentation

IVDR - From Fundamentals to Technical Documentation 

For many organizations, the transition from IVDD to IVDR has proven to be challenging — particularly in the areas of technical documentation, clinical evidence, and risk management. For manufacturers of new devices, this is also highly important, as devices must comply with IVDR requirements before being placed on the market.

Most IVD devices are now also assessed by a notified body, which adds an additional layer to the conformity assessment process.

This training provides a clear and practical approach to understanding and applying IVDR requirements within your organization. It also explains the role and processes of the notified body in the IVDR conformity assessment. 

Training is conducted in Finnish, the training material in English
 
Date and location:

May 7th, 2026
10 am – 4 pm (Registration and breakfast starting 9.30 am)
Juju Kampus, Takomotie 8, 00380 Helsinki