What is the event about?
If you have an interest in IVDR; look to increase your regulatory knowledge, are involved in bringing devices to market, or you are in the process of designating a Notified Body and want to learn more about BSI Regulatory Services, this is the event for you.
What will participants gain?
- An understanding of the IVDR current state of play, including timelines and updates
- Learn what a good IVDR submissions look like and hear common questions raised in the process
- The opportunity to engage with experts in a Q&A session
- The chance to network with BSI experts and industry peers
What are we going to talk about?
The European Parliament vote to delay the IVDR transition, allows additional time for IVD manufacturers to transition to the new regulation but there are still many challenges in achieving CE marking. This is a unique opportunity to understand the key IVDR topics and interact in person with the BSI team of IVDR experts.
Agenda
26 November, 18:00-20:00 CET
Get Together session – All speakers will be present during the evening reception, so, please join us.
27 November, 08:30-17:00 CET
IVDR Status Quo
QMS under IVDR
IVDR - lessons learnt
IVDR application process
Ask the Experts Q&A session
Workshops (participants to select one of the following sessions to attend):
• Software and AI requirements
• Technical files under IVDR
• Maintaining compliance – IVDR Post Certification activities
Don't miss the chance to meet and connect with our IVDR experts and commercial team to address your IVDR challenges and key questions.
Who should attend?
IVD manufacturers, IVD entrepreneurs, quality managers, regulatory affairs managers/directors and IVD consultants.
Dates
26 November 2024: Get together session (18:00-20:00 CET)
27 November 2024: IVDR meeting (09:00-17:00 CET)
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.
