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MedTech Summit
15 - 18 June 2026
JW Marriott Hotel Berlin, Berlin, GermanyAttend In-Person or 100% Digitally
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Day 3 - Wednesday 17th June - CEST Time Zone

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Day 3 - Wednesday 17th June - CEST Time Zone
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Showing 1 of 1 Streams
09:00 - 09:05
Chairperson Remarks
09:05 - 09:50
The Future of Clinical Evidence in the Medical Device Lifecycle
  • Exploring the evolving role of clinical evidence in the medical device lifecycle, from development to post-market surveillance, and its impact on regulatory compliance.
  • Discussing innovative approaches to generating, managing, and leveraging clinical data to meet the increasing demands of global regulatory bodies.
  • Looking into future trends, challenges, and opportunities in clinical evidence generation to support device safety, efficacy, and market success.
  • Nebojsa Serafimovic - Assessor for Clinical Investigations, Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
  • Adam Kleinman - Associate Director, Medical & Scientific Writing, Philips
  • Tonia Jeiter - Senior Manager Clinical Evaluation and Clinical Lifecycle Management, Alcon
  • Barbara Fink - Associate Director of Clinical Affairs, Heartstream
  • Andriani Daskalaki - Clinical Expert/Regulatory, mdc medical device certification
09:50 - 10:20
Spotlight Opportunity Reserved
  • Lorenz Strehl - Head of Sales Enterprise, Flinn.ai
10:20 - 11:05
Legacy Devices in Focus: Leveraging Clinical Evidence and PMS Strategy for 2027 Compliance
  • Addressing the difficulty of generating sufficient clinical data for legacy devices to meet MDR/IVDR standards
  • Exploring how manufacturers can implement robust PMS and post-market clinical follow-up plans amidst resource constraints.
  • Examining the lack of alignment and consistency MDR/IVDR interpretations - what are the solutions?
  • Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
  • Shelley Jambresic - Group Lead Science & Evaluation, Geistlich Pharma AG
Showing 1 of 1 Streams
11:35 - 12:20
Unlocking In Silico Trials in Medical Devices: The Path to Adoption
  • Alejandro Frangi - Bicentenary Turing Chair in Computational Medicine / UK CEiRSI Executive Director, University of Manchester
12:20 - 12:50
Beyond the Hype: In Silico Trials in Medical Devices, in Practice

For more information, please contact Neha Singh at neha.singh@informa.com

  • Alejandro Frangi - Bicentenary Turing Chair in Computational Medicine / UK CEiRSI Executive Director, University of Manchester
12:50 - 13:20
Clinical Investigations in the UK – Delving into Past Insights and Future Opportunities
  • Diving into current challenges and opportunities in aligning PMS practices with UK-specific regulatory requirements
  • Exploring future trends and strategies for navigating the UK regulatory landscape while ensuring robust PMS compliance
  • Mark Gumbridge - Head of Clinical Investigations, MHRA
Day 2 - Tuesday 16th June
NextDay 4 - Thursday 18th June
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