6th Qserve MedTech Conference

About This Event

The 6th Qserve MedTech Conference brings together medical device and IVD professionals, manufacturers, industry leaders (Philips, IQMessenger, Thermo Fisher Scientific, CellCarta, Corcym and more) and Notified Bodies (TÜV SÜD, BSI, DEKRA, DQS, GMED, and more) to explore how evolving regulatory, clinical and technical requirements affect product development, compliance and market access. This mixture gives attendees the perspectives of consultants, manufacturers, clinical specialists, legal experts and assessors. The programme consists of: 10 November: A practical pre-conference workshop day 11–12 November: Two conference days featuring plenary sessions, expert panels, five parallel tracks, live demonstrations and networking The programme opens with plenary sessions and in-depth discussions on the current implementation of the MDR and IVDR. The day follows with track sessions along the following topics: - Digital Health (Software, AI in Medical Devices, Cybersecurity and digital omnibuses) - General and Start-Ups (QMS, Clinical Challenges, Start-Up Survival Guide and more - IVD (IVDR Readiness & CDx Submissions) - Global Registrations (EUDAMED, Regulatory Intelligence and PRRC role) - Clinical (High-Risk Clinical Investigations, PMS, PMCF, Risk Management and more) Pre-conference workshops The workshop day provides deeper, interactive training on: Real-World Data, Design Controls, Intended Purpose & eQMS, Agile Software Development, Biocompatibility and more Who should attend. The conference is particularly relevant for: - Regulatory affairs and quality professionals - Clinical affairs, clinical evaluation, PMCF and PMS teams - Software, AI, cybersecurity and product-development specialists - IVD and companion-diagnostic professionals - PRRCs and global market-access teams - MedTech founders, executives and start-up leaders - Professionals preparing MDR, IVDR, FDA or international submissions - Teams responsible for EUDAMED, regulatory intelligence or QMS implementation - Investors and business-development professionals evaluating regulatory risk What attendees will take away. Attendees should leave with: - A clearer understanding of how MDR, IVDR, AI, software and data regulations are evolving; - Practical methods for improving submissions and interactions with regulators and Notified Bodies - Strategies for generating proportionate clinical and PMCF evidence - Guidance for integrating PMS, PMCF, risk management and clinical evaluation - Tools for strengthening QMS, software, cybersecurity and regulatory-intelligence processes - Greater clarity on European, US and global market-access pathways - Lessons from real investigations, submissions and manufacturer experiences The event is fully in-person, there will be no session recordings for remote attendees.