On September 30th and October 1st, more than 90 MedTech experts gathered in Arnhem for the 4th Qserve MedTech Conference.
On the first day of the conference, Gert Bos, Executive partner, welcomed our attendees and talked about the latest news from Brussel regarding the MDR. Following Gert's introduction panel members Hulda Hallgrímsdóttir (Össur), Bassil Akra (TÜV SÜD) and Sue Spencer (Qserve) joined Gert on stage for a presentation. During the panel presentation, the panel members spoke about different perspectives regarding the upcoming MDR and IVDR.
Those present joined a workshop on MDR or IVDR. During the MDR workshop, Gert Bos, Hulda Hallgrímsdóttir and Bassil Akra spoke about the major changes in MDR and how these can be implemented practically. Examples were given and it was discussed what manufacturers can do to minimize the risk of product withdrawal. More than 60 attendees listened attentively to the experiences and asked strong substantive questions.
During the IVDR workshop, Sue Spencer held her presentation about the practical guide for the transformation from IVD to IVDR. Sue discussed the main impacts of the transformation, how to prepare a practical GAP- Analysis and what Notified Bodies expect in a technical file.
The second day of the conference was devoted to in-dept workshops with different themes. The following speakers and workshops filled the second day of the Conference:
- Clinical by Wiebe Postma (Qserve) and Giovanni Di Rienzo (Qserve)
- PMCF/PMS by Bassil Akra (TÜV SÜD) and Stephanie Valk (Qserve)
- UDI and EUDAMED by Paul van Geffen (Qserve) and Agnieszka Schreiber (Qserve)
- US Market Access (FDA) by Mark Agostino (Qserve) and Susan Klymowski (Qserve)
- China Market Access (NMPA) by Micheal Yan (Qserve)
- Auditing and Compliance by Peter Reijntjes (Qserve), Sue Spencer (Qserve), and Juliana Remijn (Philips)
- Economic Operator by Rene Schings (Qserve) and Erik Vollebregt (Axon Lawyers)
After an interesting morning full of new information, exciting discussions and questions, it was time for lunch and the closing session with a summary of all in dept workshops and Q&A with the panel members. We look back on a successful event with interesting workshops, interesting discussions and panel presentations.
Watch our after movie of the 4th Qserve MedTech Conference:
Our Executive Team shares its key messages of the Conference:
Bassil Akra (TÜV SÜD), Hulda Hallgrímsdóttir (Össur) and Gert Bos share their key messages from the MDR workshop: