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Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: Clinical Evaluation - Optimizing Clinical Data and State-of-the-art Searches for MDR Compliance
Location: Studio 211 (level 2)
Speaker: Christiane Reinwald, PhD (Dr. rer. nat.) – be-on-Quality GmbH
Speaker: Mette Stoedter, PhD (Dr rer medic) (she/her/hers) – be-on-Quality GmbH
Speaker: David John Mandley, PhD (he/him/his) – NAMSA
Medical Devices
Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: PMS Process- dos and Don'ts
Location: Studio 212 (level 2)
Speaker: Vaso Basinou, PhD (she/her/hers) – Freelancer
Speaker: Ivan Stoyanov, Dr. – SGS Notified Body, 1639
Speaker: Andrea Biasiucci, PhD – confinis
Speaker: Claudio Alberti, PhD (he/him/his) – confinis
Medical Devices
Wednesday, May 14th
08:30 - 09:30 CEST
Innovating Regulation: The Use of AI by Notified Bodies for Conformity Assessment
Location: Silver Hall (level 0)
Moderator: Susana de Azevedo Wäsch – Ypsomed
Speaker: Ingela Mauritzon, MSc (she/her/hers) – Halmstad University
Speaker: Daniela Seneca, MEng (she/her/hers) – BSI
Speaker: Sebastian Fischer – TÜV SÜD Product Service GmbH
Medical Devices
Wednesday, May 14th
08:30 - 09:30 CEST
MDR Kick-off Panel
Location: Gold Hall (level 0)
Speaker: Gert W. Bos, PhD FRAPS – QServe Group
Speaker: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Speaker: Maria-Chiara Orlandi – European Commission
Speaker: Martin Witte (he/him/his) – TÜV SÜD Medical & Health Services
Speaker: Stephan Affolter – Ypsomed AG
Medical Devices
Wednesday, May 14th
10:45 - 11:45 CEST
“Appropriateness” of Clinical Data – Clinical Evaluations Based on Non-clinical Data Only
Location: Copper Hall (level 0)
Speaker: Elisabeth Oltmanns, M.Sc. (she/her/hers) – Escentia GmbH
Speaker: Michael D'Agosto, Prof Dr (he/him/his) – Hochschule Furtwangen University
Speaker: Breda kearney, BSc, MSc – BSI
Medical Devices
Wednesday, May 14th
10:45 - 11:45 CEST
Global Perspectives on Usability and Human Factors Studies in Regulatory Submissions: Navigating the US, EU, and China Landscape
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Beat U. Steffen, MSc, RAC, FRAPS (he/him/his) – confinis ag
Speaker: Yan Sheng, PhD – China Med Device, LLC
Speaker: Jenny Wu
Speaker: Monica Tavanti, PhD – CSL Behring
Medical Devices
Wednesday, May 14th
12:00 - 13:00 CEST
Changes in U.S. Politics: Implications for Submissions and Agency Collaboration
Location: Silver Hall (level 0)
Speaker: Amra Racic – Veeva MedTech
Speaker: Gertjan Geelen, MSc – dsm-firmenich Biomedical
Speaker: Nataliya Deych (she/her/hers) – Edwards Lifesciences Sarl
Medical Devices
Wednesday, May 14th
12:00 - 13:00 CEST
Maximizing the Value of Clinical Data for Global Submissions (EU/China)
Location: Studio 211 + 212 (level 2)
Session Leader: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Maria Camara Torres, PhD – Qserve Group
Speaker: Yu Jin, MD, PhD (she/her/hers) – Notified Body 1639, SGS Belgium
Speaker: Yan Sheng, PhD – China Med Device, LLC
Speaker: Johanna Sorsa, Dr (she/her/hers) – Siemens Healthineers AG
Medical Devices
Wednesday, May 14th
14:30 - 15:30 CEST
Clinical Data Challenges for Novel and Legacy Medical Devices - Panel Discussion with Clinical Experts from Multiple Notified Bodies
Location: Gold Hall (level 0)
Moderator & Presenter: Matthias Fink – AKRA TEAM Inc.
Speaker: Richard G. Holborow, n.a. (he/him/his) – BSI
Speaker: Ulrich Nitsche, MD, PhD (he/him/his) – TÜV SÜD Product Service GmbH
Speaker: Christoph Ziskoven (he/him/his) – TÜV Rheinland LGA Products GmbH
Speaker: Paul Piscoi – European Commission - Directorate-General for Health and Food Safety
Medical Devices
Wednesday, May 14th
14:30 - 15:30 CEST
EU Green Deal
Location: Studio 211 + 212 (level 2)
Speaker: Erik R. Vollebregt – Axon Lawyers
Speaker: Sonja Hirte, PhD (she/her/hers) – PRO-LIANCE GLOBAL SOLUTIONS
Speaker: Anja Siegemund
Medical Devices
Thursday, May 15th
08:30 - 09:30 CEST
EUDAMED Unlocked: Navigating the Current Landscape and Implementation Strategies
Location: Silver Hall (level 0)
Speaker: Patrick Pille, Dr – MDSS GmbH
Speaker: Richard Houlihan, MBA BSc – EirMed Ltd
Medical Devices
Thursday, May 15th
08:30 - 09:30 CEST
The Power of Teamwork: Risk Management, Clinical Evaluation and PMS Aka “the Holy Trinity of the MDR” – but What About Claims?!
Location: Copper Hall (level 0)
Moderator: Robert A. van Boxtel – Medical Device Project B.V.
Speaker: Sarah Panten – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker: Alexej Agibalow, n/a – Escentia GmbH
Speaker: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Medical Devices
Thursday, May 15th
10:45 - 11:45 CEST
Revolutionizing Product Safety and Performance: The Role of Computational Modelling, in Silico Trials, and Global Standards
Location: Gold Hall (level 0)
Speaker: Gavin Quigley, MBChB FRCS MBA – British Standards Institution
Speaker: Alejandro Federico Frangi, FREng FIEEE – University of Manchester
Speaker: Jeff Bischoff, PhD – Zimmer Biomet
Speaker: Michael Kipping, PhD – Element Materials Technology | University of Manchester
Medical Devices
Thursday, May 15th
10:45 - 11:45 CEST
UK Regulatory Landscape: UK MDR Amendments and Impact
Location: Studio 211 + 212 (level 2)
Moderator: Sue Spencer – Compliance Connextions Limited
Speaker: Monisha Phillips (she/her/hers) – TUV SUD
Speaker: Vishal Thakker, MEng (he/him/his) – BSI
Speaker: Robert Reid (he/him/his) – MHRA
Medical Devices
Thursday, May 15th
12:00 - 13:00 CEST
Navigating the Intersection of MDR and HTA: Strategic Implications for Medical Device Manufacturers
Location: Silver Hall (level 0)
Session Leader/Speaker: thomas miramond – NAMSA
Medical Devices
Thursday, May 15th
12:00 - 13:00 CEST
PSUR: Requirements, Experiences and Lessons Learned to Date from Three Stakeholder Perspectives
Location: Gold Hall (level 0)
Moderator & Presenter: Jenifer Hannon, MTOPRA (she/her/hers) – BSI
Speaker: Sietske Eerens (she/her/hers) – Dutch Health and Youth Care Inspectorate (IGJ)
Speaker: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Medical Devices
Thursday, May 15th
14:30 - 15:30 CEST
Benefits of Standardized Data Models for Digitalization in the Medtech Industry
Location: Copper Hall (level 0)
Session Leader: Sarah Panten – avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Speaker: Daniel Prell, MBA, Dr. (he/him/his) – Siemens Healthineers AG
Speaker: Frédéric Said, n/a – Siemens Healthineers AG
Medical Devices
Thursday, May 15th
14:30 - 15:30 CEST
Using IMDRF Codes to Analyse Complaints and Connections with Risk Management
Location: Silver Hall (level 0)
Moderator & Presenter: Keith Morel, PhD (he/him/his) – Qserve
Speaker: Gregory Duby
Medical Devices
Thursday, May 15th
16:45 - 17:45 CEST
Bringing Innovative Medical Devices to the EU Market
Location: Silver Hall (level 0)
Moderator: Giovanni Di Rienzo – Edwards Lifesciences
Speaker: Ana Matos Machado, MD – Tuv Sud
Speaker: Javier Castillo, MSc EMBA – INBRAIN Neuroelectronics
Speaker: Alberto Ganan, PhD – European Medicines Agency
Medical Devices
Thursday, May 15th
16:45 - 17:45 CEST
China: Key Regulatory & Clinical Updates and Their Implementation
Location: Studio 211 + 212 (level 2)
Speaker: Grace F. Palma, MBA (she/her/hers) – China Med Device, LLC
Speaker: Hamish King, RAC, LLB – Cisema
Speaker: Xiaowei Sun, M.D & Ph. D (she/her/hers) – Royal Philips
Medical Devices
Friday, May 16th
10:30 - 11:30 CEST
All in One for Biocompatibility: ISO 10993 Updates, Toxicological Risk Assessment and Post-market Data
Location: Gold Hall (level 0)
Session Leader: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Marina Daineko, MSc (she/her/hers) – Intrinsic Medical Group
Speaker: alessia frabetti, PhD (she/her/hers) – Kiwa Cermet Italia SPA
Speaker: Jeremy Tinkler, ERT – ICON plc
Medical Devices
Friday, May 16th
10:30 - 11:30 CEST
On Trend: The Important Considerations for Trend Reporting in Medical Device Safety
Location: Studio 214 + 216 (level 2)
Speaker: Edward Ball, CEng MIPEM (he/him/his) – RQM+
Speaker: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Speaker: Ashley Stratton-Powell
Speaker: Sofia Prata, PhD – DQS
Medical Devices
Friday, May 16th
11:45 - 12:45 CEST
Medical Device – International Focus: Global Reliance on CE Mark and Industry Strategies
Location: Studio 214 + 216 (level 2)
Moderator: Jennifer Neff, PhD – Entourage GmbH
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Speaker: Nada Alkhayat – European Commission
Speaker: Dennis Sarwin, MSc – Qserve Consultancy BV
Medical Devices
Friday, May 16th
11:45 - 12:45 CEST
Orphaned Devices - The Needs, Approval Process and Challenges in the EU
Location: Gold Hall (level 0)
Moderator & Presenter: Tom Melvin, n.a. – Trinity College, Dublin
Speaker: Richard G. Holborow, n.a. (he/him/his) – BSI
Speaker: Leo Hovestadt – Elekta
Speaker: Nona Heueis, Phd (she/her/hers) – Heraeus Medical GmbH
Medical Devices