We are excited to welcome you to the 6th Qserve MedTech Conference. For three days, around 100 professionals from regulatory affairs, quality and clinical come together to talk about what is changing in MedTech right now: MDR and IVDR in practice, AI and software, Europe’s new digital health rules, EUDAMED and the evidence you need to stay on the market.
The programme has 8 hands-on workshops, 22 sessions across five parallel tracks and 4 plenary sessions that bring everyone together. Pick your own route through the tracks, ask the questions you came with, and use the breaks to meet the people who face the same challenges, and the ones who review your files.
All sessions are on the first floor. Follow the “Upstairs” signs from the lobby. Tap a room to see where it is.
Choose a day to see the full programme with times and rooms. All times are CET.
Bianca Lutters
Build a future-proof real-world data strategy aligned with regulatory requirements and organisational goals, and learn when RWD adds the most value.
Robert Paassen & Jorn van Binsbergen
Define intended purpose and claims that support your regulatory strategy, structure design controls, and see how an eQMS streamlines traceability.
Coenraad Davidsdochter
Align Agile workflows with IEC 62304, ISO 13485 and evolving frameworks while keeping traceability, documentation and risk control.
Lorry Weaver & Inette Nieveen
A practical guide to pre-submissions, 510(k), IDE, PMA, HDE and Breakthrough Device Designation, and how to pick the right route.
Jorn van Binsbergen & Wouter Mattheussens
Design, collect and use real-world data for PMCF and registry-based studies: data sources, study design, governance and integration.
Bianca Lutters
What the updated standard requires, and how to plan, assess and document biocompatibility, including when testing is needed and when a justification will do.
Coenraad Davidsdochter
Continuation of the morning session.
Lorry Weaver & Robert Paassen
Regulatory pathways, strategy and evidence packages for bringing breakthrough devices to market in both the EU and the USA.
Moderator: Gert Bos (Qserve)
Speakers from across the programme connect the dots between regulatory developments, clinical evidence, quality systems and emerging technologies.
Gert Bos (Qserve)
The current state of MDR implementation, the challenges manufacturers face and the developments likely to shape what comes next. Closes with Q&A.
Experts from the IVD ecosystem
Challenges, lessons learned and how to prepare for the next phase of IVDR implementation. Closes with Q&A.
Coenraad Davidsdochter (Qserve), Malte Knowles-Schmidt (TÜV SÜD) & Beatrice Federici (TU Eindhoven)
How AI-driven devices are regulated under MDR, IVDR and upcoming guidance, and what that means for clinical evaluation, risk management and submissions.
Francois Naye (Qserve), Gunnar Ulrich (DNV) & Frédéric Daval (Kinetec)
Move beyond check-the-box compliance to a QMS that supports your teams and business goals.
Kristiane Schmidt (Qserve), Molly Rogers (DNV) & Martin van Vliet (Skyline Dx)
IVDR compliance from the view of large manufacturers, SMEs, start-ups and Notified Bodies, with help to spot your own gaps.
Wouter Mattheussens (Qserve) & Sara Haimanot (DEKRA)
Real-world experience from a novel heart valve case: requirements, challenges and success factors.
Coenraad Davidsdochter (Qserve) & Cecile van der Heijden (Axon Lawyers)
Regulatory, technical and clinical considerations for digital health: interoperability, cloud, data exchange and integration.
Gert Bos & Lorry Weaver (Qserve), Malte Knowles-Schmidt (TÜV SÜD), Benedetta Romanelli (BSI) & Daan Pelgrom (DEKRA)
Prepare for and manage interactions with regulators and Notified Bodies: ask the right questions and present your case clearly.
Daphne Smit (Qserve), Maurice Steenhuis (CCMO) & Julie Mutert (CellCarta)
Lessons learned from CDx submissions and how to navigate their unique regulatory challenges.
Jorn van Binsbergen (Qserve), Yun-Hsuan Chang (Scarlet) & Floor van Leeuwen (IQMessenger)
Practical guidance on demonstrating clinical performance and safety for software and AI.
Moderator: Gert Bos (Qserve)
Track leads share the key takeaways of the day, followed by an open mic for the audience.
Qserve Clinical team
How Qserve uses AI to make parts of its clinical services more efficient while staying compliant.
Qserve Regulatory Intelligence team
A guided tour of the InSight regulatory intelligence platform.
Qserve Learn team
Everything about the training platform for the MedTech and IVD sectors.
Free 10-minute massage in B-House, walk in between 18:30 and 20:30.
Moderator: Gert Bos (Qserve)
How AI is reshaping regulatory science and intelligence, from conformity assessment to hospital care, followed by a panel discussion.
Cornelia Luban (Qserve), Dr. Andrei Ninu (DQS) & Stefan Leitenberger (Philips)
Software lifecycle and risk management under IEC 62304 and ISO 14971, with practical documentation guidance.
Robert Paassen & Lorry Weaver (Qserve), Matthias Bellmann (TÜV SÜD) & Daniele Zanotti (StarTric)
The most common start-up pitfalls and how to prioritise resources and build a scalable regulatory strategy.
René Schings (Qserve) & Golo von Basum (Stentit)
What the Person Responsible for Regulatory Compliance is accountable for under MDR and IVDR, and the ethical questions that come with it.
Wouter Mattheussens (Qserve), Richard Holborrow (BSI) & Martin Stofanko (Adaptix)
Survey design principles, common pitfalls and how to collect high-quality PMCF data.
Mike Szymonik (Qserve) & Steven Byrne (Scarlet)
Implement cybersecurity across the product lifecycle in line with MDR, IVDR and international guidance.
Robert Paassen & Bianca Lutters (Qserve), Richard Holborrow (BSI) & Daniele Zanotti (StarTric)
Design and run clinical activities efficiently with limited resources.
Dennis Sarwin (Qserve) & Adelina Chiaravalloti (Corcym)
Build an efficient regulatory intelligence system: sources, tools, filtering and prioritisation.
Bianca Lutters (Qserve) & Marcus Torr (Purdie Pascoe)
Low-burden PMCF strategies that use PMS data, complaints, literature and registries.
Networking roundtables in Taurus 2 from 13:30 to 14:00.
Mike Szymonik (Qserve) & Floor van Leeuwen (IQMessenger)
How Europe’s digital health rules interact, and how to stay compliant while using health data for innovation.
Bianca Lutters (Qserve), Benedetta Romanelli (BSI), Marx Bernd (Vygon) & Manfred Lubberich (ProMDService)
Common mistakes and best practices for a compliant, effective submission file.
Dennis Sarwin (Qserve) & Adelina Chiaravalloti (Corcym)
EUDAMED’s modules, common implementation challenges and practical tips.
Jorn van Binsbergen (Qserve), Inge Willems (DEKRA), Daphne Zwartjes (TSC-Life) & Albina Torre (Haleon)
Align PMS, PMCF, risk management and clinical evaluation by sharing updates efficiently.
Panel with final Q&A
How to build regulatory resilience, spot signals of change early and prepare when the future is not yet clear.
Practical information for your stay at the venue.
Novotel Amsterdam Schiphol Airport, Taurusavenue 12, 2132 LS Hoofddorp. The hotel is not at the airport itself: take the train from Schiphol Plaza to Hoofddorp (one stop, about 4 minutes) and walk a few minutes from the station. From Amsterdam Centraal, direct trains to Hoofddorp take about 20 minutes.
The hotel is directly reachable from the A4 and A5. The adjacent parking garage has around 400 spaces and charging points for electric cars.
The conference is on the first floor. Every room has a roll-up at the door showing what takes place there, so you can check you are in the right room at a glance.
Need to take a call or catch up on email? Taurus 2 is a Work Zone, open all day on Wednesday and Thursday. On Thursday it also hosts the networking roundtables from 13:30 to 14:00.
Coffee, tea and lunch are included every day. Let the registration desk know about any dietary requirements or accessibility needs and we’ll arrange it with the venue.
Stay for dinner and the evening programme from 17:30. Between 18:30 and 20:30 you can walk into B-House for a free 10-minute massage. MDR: Massage Done Right.
Find a Qserve team member at the registration desk, or email training@qservegroup.com.
