Day 1 - Monday 15th June - CEST Time Zone
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD
- Paul Piscoi - Policy Officer, Directorate-General Health & Food Safety, Unit D.3 Medical Devices, European Commission
Examining how EU MDR/IVDR revisions are reshaping the definition of risk acceptance in medical device and IVD development.
Adapting to change - providing actionable insights for manufacturers to align risk management practices with the new regulatory expectations.
- Gert Bos - Executive Director & Partner, Qserve Group
- Maximilian Reuter - Senior Director Systems Solutions Data Program Management, Regulatory Affairs Operations, Person Responsible for Regulatory Compliance, Olympus Europa
- Svetlana Bykanova - Chief Quality Officer, HOYA Vision Care
- Silke De Zolt - Section Manager IVD Devices, TÜV Rheinland
- Giacomo Cargnello - Head of Quality Assurance & Regulatory Affairs, C&C Solutions, Varex Imaging
- Marta Carnielli - Head of Certification IVD, TÜV SÜD
- James Shearn - Director, Regulatory Intelligence & Policy, Steris
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
- Highlighting the latest regulatory changes and their implications for accelerating innovation in the MedTech sector.
- Addressing common hurdles and lessons learned to guide stakeholders in bringing breakthrough devices to market successfully.
- Exploring how SMEs can best leverage the breakthrough medical device pathway to compete in the MedTech industry.
- Ella Helgeman - Senior Regulatory Director, Radiometer
- Esmeralda Megally - CEO & Co-Founder, Xsensio
- Gert Bos - Executive Director & Partner, Qserve Group
- Is the reliance route a viable option?
- how have classification rules changed and how do they compare with the EU?
- Key points of difference from the EU
- How might the MHRA regulate advertising in the future?
- Alison Dennis - Partner, Winston Taylor
Strategies for aligning product development and approval processes to meet diverse regulatory requirements across regions.
Exploring opportunities for harmonization and collaboration to streamline global market access and reduce regulatory complexity.
- Mahua Yasmin - Manager Regulatory Affairs EME, Johnson & Johnson
This session explores how AI can transform complex global regulations into structured, machine-readable requirements that integrate directly into engineering workflows. By connecting fragmented data from QMS, PLM, and RIM systems within a regulatory knowledge graph, AI agents can automate traceability, impact analysis, and compliance workflows. Attendees will see how this approach reduces manual effort, rework, and review cycles while keeping documentation continuously audit-ready. A real-world case study with Philips demonstrates how REMATIQ enables automated traceability from design inputs through verification and validation.
- Alyse Andre - Account Executive, Rematiq
- Exploring the objectives and key differences between the Swiss and the EU regulatory system.
- Addressing the key challenges and timelines
- Practical strategy for manufacturers to navigate swissdamed and ensure seamless market access in Switzerland.
- André Breisinger - Expert Medical Devices Regulation, Swissmedic