Umeå University has over the years delivered cutting-edge research that has led to global products within In Vitro Diagnostics (IVD). We currently have three companies operating in this area in Nordic Biomarker, Uman Diagnostics/Quanterix and Hiloprobe. We also have projects at the research stage in this area.
In 2022, the EU will tighten up the regulatory framework for diagnostic products, which will place higher demands on manufacturers when it comes to, among other things, clinical evidence, documentation, quality systems and follow-up of products on the market. The new and stronger requirements will be a challenge for the companies operating in the industry. It will also affect how the researchers plan their studies and product development.
In this context, UBI invites you to a lecture that will give you an overview of the requirements of the new In Vitro Diagnostic Regulation (IVDR). It is aimed at those who work at local companies in the industry where large parts of the organizations will be affected in order to meet the new regulations. It is also aimed at those of you at Umeå University who are researching this area and want to get an introduction to the requirements placed on a manufacturer within In Vitro Diagnostics.
1. The training will be held digitally Thursday 4 March at 13–15. Link will be sent by mail
2. Trainers are Katalin Holenyi and Julia Selmani, Key2Compliance
3. The education is sponsored by Umeå Biotech Incubator and is free of charge for companies and researchers in Umeå
4. If you have any questions, please contact andreas.lindberg@ubi.se
5. Registration is done via registration form…
Agenda
- Background
- IVDR Bricks
- Time plan
-products
-quality system - Definitions and technical file
- Classification and impact of
- Notified Body – status
- Performance evaluation – overview
- Quality management system (QMS) to fulfill regulatory requirements
- Requirements posed on specified roles
- Corrigendum, guidelines, useful documents
