09:00 - 17:00 CEST | Amsterdam
About the event
We are pleased to invite you to our in-person BSI Meet the Experts 2024 – MedTech Edition event on 11 September 2024 in Amsterdam, fully dedicated to the EU MDR. While the MDR deadline of May 26 2024 has passed, there are still many questions and challenges for the MedTech industry facing the difficulties of implementing the new regulation and the impact it has on the medical device industry. BSI is here to help you navigate the highly regulated EU MedTech sector. We have developed a dedicated event where you can explore and learn about the in and out of the MDR process from a Notified Body’s perspective. From application through conformity assessment, technical documentation, artificial intelligence, Article 117, Software as a medical device and many more.
Join this extended event to hear about the latest MDR regulatory environment for a Notified Body, IEC 60601 testing, clarification on specific MDR requirements and innovations to technical documentation submission, how to work with a Notified Body, article 117 for pharmaceutical companies, software as a medical device, artificial intelligence in medical devices and much more. Besides this is a unique opportunity to meet and connect with our MDR experts and our commercial team to address your MDR challenges and key questions.
The meeting will be preceded by a Get Together session on 10 September, 18:00-20:00 CEST where you can interact with all our speakers, so please join us.
Agenda
Welcome & Speaker Introduction - Derek Nagelkerke
Demystification of Notified Bodies - Perspectives from the British Standards Institution - Thomas Doerge
IEC 60601 testing - Paul van Meggelen
Structured Dialogue: Innovative Pathways in Europe and UK: a Legal, Manufacturer's and Notified Bodies Perspective / common technical documentation - Richard Holborow
Workshop 1
MDR & artificial intelligence - Alex Zaretsky
OR
Article 117 for pharmaceutical companies - Theresa Jeary & Godwill Iheagwaram
Workshop 2
Software as a medical device - Sreenath Sukumaran & Thomas Doerge
OR
How to best interact with a Notified Body for a successful MDR application? - Ingeborg Knol
Panel Q&A and closing remarks - all
Dates
- 10 September 2024: Reception - Get together session (18:00-20:00 CEST)
- 11 September 2024: Meet the Experts Event (09:00-17:00 CEST)
Event location
Van der Valk Hotel Zuidas, Tommaso Albinonistraat 200, 1083 HM, Amsterdam. See on map.
Registration fees
€100 per person (incl. VAT)
Note: In case of cancellation the Eventbrite admin fee will still apply.
Register here
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Source: BSI