Dear colleagues,
IVDR requires certain knowledge, framework and guidance for laboratories, which tests are falling under requirements of Regulation. ISO 15189 compliance is a necessary prerequisite, but it’s not all what IVDR asks for. To make this topic transparent, we would like to invite you to a workshop we would do short introduction:
- To current IVDR landscape, what it consists of
- To current timelines and requirements, that should be in place
- To exactly defining what is In-House test and what is not
- To automated platform, which guides through IVDR aspects step by step (such as required Intended Purpose, Risk Classification, General Safety and Performance requirements, Risk Management, Performance Evaluation)
We would be delighted to answer your questions and navigate your through this complex topic on our workshop on 18th of September at 14 p.m.! Link for registration you will receive in our next communication. We also would be present at upcoming XXXV. Izakovich Memorial 2025 conference.
More information about us and our services you can find here.
Thank you and see you soon.
Platomics Team
