Program day 1 | 11 October 2023

9:30 - 9:45 Opening 

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.

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.

Speaker profiles:

• Coenraad Davidsdochter (Qserve Group)
• Leon Doorn (Aidence)

11:15 - 12:30 IVDR - Getting Started with the IVD Regulations – Secrets to Getting it right first time

This session aims to discuss:

• Whether you are a start-up company facing IVD regulations for the first time, an IVD company planning a new project, or an IVD company in transition from the IVDD to the IVDR this session is prepared for you.
• In an interactive session, we will cover a number of key topics that manufacturers need to get right from the very start but are often overlooked.
• Intended purpose - we often talk about the intended purpose, but still, the data from NBs say this remains a leading cause of NB questions.
• We will also discuss regulatory planning for devices for maximum efficiency globally.

Speaker profiles:

• Sue Spencer (Qserve Group)
• Molly Rogers (NSAI)
• Colleen Watson (Thermo Fisher)

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. 

Speaker profile:

• Bianca Lutters (Qserve Group)
• Patrïcia da Silva Perez (Qserve Group)
• Rachel Mead (BSI)

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.

Speaker profile:

• Giovanni Di Rienzo (Qserve Goup) 
• Steve Lee (Abhi)

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.

Speaker profile:

• Henk-Willem Mutsaers (Qserve Group)
• Olena Hoi (Qserve Group)
•  Joëlle Abi Char (Nikkiso Belgium)

14:15 - 15:30 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

Speaker profile:

• Sue Spencer (Qserve Group)
• Steve Lee (Abhi)
• Molly Rogers (NSAI)

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.

• Armêl Plaine (Qserve Group)
• Jorn van Binsbergen (Qserve Group)
• Rachel Mead (BSI)

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.

Speaker profile:

• Agnieszka Schreiber (Qserve Group)
• Richard Houlihan (EirMed)

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:

• Giovanni Di Rienzo (Qserve Group)
• Sue Spencer (Qserve Group)
• Armêl Plaine (Qserve Group)
• Agnieszka Schreiber (Qserve Group)
• Colleen Watson (Thermo Fisher)
• Natascha Cuper (Kiwa)
• Leon Doorn (Aidence)
• Sabina Hoekstra-van den Bosch (TÜV SÜD)
• Erik Vollebregt (Axon Lawyers)

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.