All open seats have been reserved. New registrants will be put on a waiting list, because this seminar is full.
Our Nelson Labs’ Leuven Center of Excellence is having an open house event on 04 and 05 March 2020. This event will be a unique opportunity to broaden your understanding of the latest regulatory developments medical device manufacturers will be facing in 2020, in particular the stringent new regulations that are to take effect in May 2020 (EU MDR).
We have lined up some of the most reputable industry leaders, who will address the following key themes from several angles:
- Update on the EU MDR implementation
- Navigating changes to the ISO 10993-18 standard
- The role & view of a Notified Body
- Biological Safety Evaluation of devices (including Chemical Characterization, Irritation and Toxicological Risk Assessment)
- The processing cycle for reusable medical devices (including cleaning, disinfection and sterilization of reusable devices)
DOWNLOAD the Agenda here
This year’s keynote speakers are Ron Brown (former US FDA Senior Toxicologist), Dr Dennis Jenke (Principal Consultant Nelson Labs), Dr Ted Heise (Vice President Regulatory and Clinical Services at MED Institute), Dr Christian Pellevoisin (Scientific Director at Episkin Academy), Dr Gert Bos (Executive Director & Partner at Qserve), and many others to be announced very soon.
You are also invited to tour our lab operations and meet our expert staff!
The agenda spans two days and covers many unique and timely subjects.
- Opening speech from Nelson Labs EMEA Leader
- EU MDR
- Biocompatibility for Medical Devices
- View from a notified body
- In Vitro Irritation
- Chemical Characterization: Techniques & Instruments
- Linking the ISO 10993-17 and ISO 10993 -18
- Toxicological Safety Evaluation
- Guidance for cleaning, disinfection and sterilization of reusable devices
PLUS: Guided tour of the Laboratory Facility
AND: On-site Networking event