The MedTech Meetup in Belgium is a unique event for the medical device, IVD medical device and digital health sectors. Already for the 6th time, the company COVARTIM organises the event for the Belgian MedTech industry.
An interesting daily agenda with a wide range of expert presentations, panel discussions and the opportunity for networking and exchange await the participants.
We are very pleased that the content of this event will be enriched by a workshop on "Clinical Data for the MDR from the perspective of a Notified Body" - led by our esteemed colleagues Dr Uta Romberg and Dr Thomas Feldmann. They will also be available for meetings directly on the day of the event.
Registration and further information at: Home - MedTech Meetup 2023
What is it specifically about?
Already under the MDD, clinical data were of great importance for the approval of a medical device, the MDR has increased the requirements for these clinical data and emphasised their importance for the certification process.
In this presentation, the view of a Notified Body on clinical data will be presented. The differences between the approval of new medical devices in contrast to existing devices will be discussed. Another point will be the change in the equivalence route under the MDR, as significantly changed requirements apply here.
Who are the speakers?
Dr Thomas Feldmann is a biologist and specialist in molecular genetics. He brings 22 years of experience in the field of medical device certification at various Notified Bodies such as TÜV Rheinland as well as on the manufacturer side and has been working as an auditor for DQS Medizinprodukte since 2007. He has been Head/Deputy Head of the Notified Body at DQS MED since 2012.
Dr. Uta Romberg is a medical doctor specialising in orthopaedics and trauma surgery and has been working in the medical field for 28 years. She has been a lecturer in various subjects for 22 years, since 2008 also as a lecturer and examiner for paediatrics, general surgery and internal medicine.
She is also a lecturer for the advanced training "Resuscitation" as part of the in-house advanced training for doctors and nursing staff. Within the scope of her general activities, she works as a clinical expert and auditor for the DQS.
In addition, Ms Annemie Valkeneers from DQS Belgium and Mr Vincent Fuhrmann from our DQS MED sales team will attend as local contact persons and use this event for exchange.
