Since the MDR has been in force for some time, and the deadline for submitting an application to the Notified Body as of May 26, 2024 has passed, it is time for another extensive session in which we actually get to work. The session is 1-day, during which lunch will be provided.
The topic of this workshop session is the future of medical devices in Europe: to this end, we will start with a plenary part in which speakers from different angles will give their point of view on the future of medical devices in Europe.In the afternoon, we will dive into the practical approach during three separate workshops.
- Clinical evaluation for AI medical device software
- High-risk combination products Medical devices – pharma
- Sustainability and medical devices.
There are two rounds of workshops, so it is possible to attend two different workshops. Use cases are welcome!
Note the majority of the workshops and presentations will be conducted in Dutch with one workshop conducted in English language.
Registration Fees & Deadlines
Registration: send an email to rachapternedvl@gmail.com no later than June 14, 2024. Please indicate your preferences for the 2 workshops in your registration, with possible use cases.
Available workshops:
- Clinical Evaluation and AI MDSW
- High-risk combination products pharma and medical devices (English Workshop)
- Sustainability
When you click register, an automatic email for rachapternedvl@gmail.com will appear. Please fill out the above information and send the email to register
Contribution: Following registration, we ask you to pay a contribution of €20. You will receive a confirmation email with the details of the banking information and how to submit payment directly to the RAPS Netherlands Chapter.
Agenda
| Time |
Topic |
Speaker |
| 10:00 |
Reception and registration |
|
| 10:30 |
Opening and welcome by RAPS Chapter chairman |
Anja Wiersma |
| 10:35 |
Introduction by host |
Signifix |
| 10:45 |
News that touches us |
Natascha Cuper |
| 11:00 |
Plenary:
Future of medical devices in Europe |
Ruud Verdaasdonk
Cas Mevissen
Erik Vollebregt |
| 12:15 |
Lunch |
|
| 13:15 |
Workshop round 1:
Clinical Evaluation and AI MDSW |
Bianca Lutters
Joline van Sorge |
| 13:15 |
Workshop round 1:
High-risk combination products pharma and medical devices (English Workshop) |
Jeroen Pieper
Theresa Jeary
Laurent Ferrière |
| 13:15 |
Workshop round 1:
Sustainability |
Claire Hostmann
Janny Boekhout
Rick Paauw |
| 14:45 |
Coffee, tea break |
|
| 15:15 |
Workshop round 2:
Clinical Evaluation and AI MDSW |
Bianca Lutters
Joline van Sorge |
| 15:15 |
Workshop round 2:
High-risk combination products pharma and medical devices (English Workshop) |
Jeroen Pieper
Theresa Jeary
Laurent Ferrière |
| 15:15 |
Workshop round 2:
Sustainability
|
Claire Hostmann
Janny Boekhout
Rick Paauw |
| 16:45 |
Wrap-up with thanks to speakers |
|
| 17:00 |
Closing drinks |
|
Speakers
Natascha Cuper
Clinical Expert and Product Reviewer, Kiwa Dare Medical Certifications
Ruud Verdaasdonk
Professor of Health Technology Implementation, University of Twente
Cas Mevissen
Policy Officer Digital Economy, Ministry of Economic Affairs and Climate
Claire Hostmann
Senior policy advisor on security of supply for medical devices and Coordinator of Sustainable Medical Products at the Ministry of Health, Welfare and Sport
Rick Paauw
Quality & Regulatory Manager, Medtronic
Location
Fort de Batterijen
Overeindseweg 25
3439 LP Nieuwegein
Cancellations and Refunds
Please email all cancellations and refunds to rachapternedvl@gmail.com
Substitutions
Please request all substitutions to rachapternedvl@gmail.com
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions