5th Qserve MedTech Conference 2023
The conference will address 25 years of sharing global
knowledge with the MedTech industry. Qserve’s internal
hosts will present a diverse program with industry speakers,
Notified Bodies, and Competent Authorities. Learn how we
use our practical approach by bringing our expertise to the
field in guiding regulatory, quality, and clinical processes to
achieve full compliance.
Program of 11 October 2023
You will be welcomed to the 5th Qserve MedTech Conference by the Board of Qserve, Jan van Lochem, Gert Bos, and Martin de Bruin.
9:45-11:00 Hot Issues in Europe
In this opening panel, Gert Bos (Qserve Group) will explore the latest developments and hot issues straight from Brussels in a moderated debate.
Gert will be joined by Natascha Cuper (Kiwa)
, Sabina Hoekstra-van den Bosch (TÜV SÜD)
and Erik Vollebregt (Axon Lawyers).
11:15-12:30 Medical Device Software in the EU
This workshop aims to give an overview of current and upcoming regulations and their impact on medical device manufacturers.
11:15-12:30 IVDR - Lessons Learned and Challenges to Come
The aim of this session is to discuss:
- Greatest pain points from the perspective of a manufacturer. What do I wish I knew at the outset?
- Feedback from notified body reviews greatest pitfalls
- Challenges ahead to meet the transitional arrangements
- Staying on the market – Post-Market surveillance and PMPF plus technical file sampling and changes to devices
11:15-12:30 Periodic Updates of the Clinical Evaluation
This session will focus on optimizing the updates from clinical and post-market perspectives. For example, having literature searches and adverse events searches as separate documents could be used for the clinical evaluation and for the PMS/PMCF activities.
11:15-12:30 UKCA Strategy
This session will give insight into the requirements for the Great Britain market. Learn what is necessary from a regulatory perspective and what type of effort is required from a quality team.
14:15-15:30 Effective Supplier Control and Audits
In this session, you will learn how to effectively control your critical suppliers. Special attention will be given to conducting effective supplier audits.
14:15-15:30 IVD Go-To-Market Strategies to Focus on FDA
Traditionally IVD manufacturers entered the EU market before looking at the US and ROW. Extended review timelines are pushing manufacturers to think differently and look at the US first. This session will cover go-to-market strategies and secrets to a successful submission.
14:15-15:30 Design of Clinical Studies
This session will focus on how to design a proper clinical study and the importance of involving regulatory knowledge in the design.
14:15-15:30 Identification and Traceability
This session will explain more about the upward trend in the traceability of medical devices by using unique device identification.
16:00-17:15 Panel Show
The day's final panel will bring the speakers of the various sessions and sessions back together to address the questions from the audience. The following speakers will join host Gert Bos on stage:
17:15-21:30 Festive evening program
We close the first day of the conference with networking and drinks, followed by a festive dinner and evening program.