About the event
We are happy to invite you to our in-person annual BSI Meet the Experts meeting in Amsterdam on 2 November 2023, fully dedicated to the EU IVDR. With the IVDR having entered into force on 26 May 2022, there are still many questions and challenges for IVD manufacturers facing the difficult task of implementing the regulation.
Join this extended meeting to hear about the latest IVD regulatory updates, clarification on specific IVDR requirements and lessons learnt related to Performance Evaluation, QMS, Technical documentations submission, PMS and much more.
Don’t miss this unique opportunity to meet and connect with our IVDR experts and with the commercial team to address your IVDR challenges and key questions.
The meeting will be preceded by a Get Together session on 1 November, 18:00-20:00 CET. All speakers will be present during the evening reception on 1 November so please join us.
|Welcome & Speaker Introduction||Victoria Cox|
|Status Quo of the IVDR & Class D Updates||Alex Laan|
|IVDR Application: Streamlining the application process||Charlotte Hess|
|Technical Documentation: Common pitfalls||Sara Fabi, Ana Chiva|
|QMS for IVD manufacturers: Lessons learnt||Clemens Busse|
|Performance & Clinical best practice||Elizabeth Harrison, James Kerr|
Post Market Surveillance (PMS)
Update on UKCA
|Panel Q&A & closing remarks||All|
- 1 November 2023: Get together session (18:00-20:00 CET)
- 2 November 2023: IVDR meeting (09:00-17:00 CET)
Mercure Hotel Amsterdam City, Joan Muyskenweg 10, Amsterdam – 1096CJ
See Google Map
€100 per person (incl. VAT)
Note: In case of cancellation the Eventbrite admin fee will still apply.