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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 4 - Thursday 18th June - CEST Time Zone

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Day 4 - Thursday 18th June - CEST Time Zone
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08:30 - 09:00
Day 4 Registration
Showing 3 of 3 Streams
09:00 - 09:05
Chairperson Remarks
  • Bianca Lutters - Head of Clinical Affairs and Principal Consultant, Qserve Group
09:05 - 09:50
Case Study Conversation: ISO/ DIS 18969
  • Highlighting the development, implementation, and impact of the ISO/DIS 18969 standard within the medtech industry.
  • Insights into overcoming regulatory hurdles, technical complexities, and industry-specific challenges during the adoption of ISO/DIS 18969.
  • Milos Stojkovic - Safety Process Director, Roche
09:50 - 10:20
Sufficient Clinical Evidence for High Risk Medical Devices
  • Discussion of the requirement for clinical investigations
  • What is “sufficient” clinical evidence and how to demonstrate this to your notified body?
  • How to develop an effective Clinical development plan and clinical strategy
  • Leveraging clinical data from other regions
  • Susan Partridge - Clinical Regulatory Lead, BSI
10:20 - 11:05
Case Study Conversation: Diving into ISO 14155
  • Introduction to the key updates and enhancements in the new version of ISO 14155
  • Case studies and actionable insights to adapt to ISO 14155:2025, ensuring smooth implementation and alignment with global standards
  • Danielle Giroud - Convener, TC 194 WG4 for the ISO 14155
09:00 - 09:05
Chairperson Remarks
  • Priscilla Lemes - Regulatory Affairs Specialist - Product Life Cycle EMEACLA, Edwards Lifesciences
09:05 - 10:35
China’s Regulatory Pathways for Medical Devices: The NMPA System Explained
  • Practical examples illustrating the steps required for product registration, clinical evaluation, and market approval under the NMPA system.
  • Case studies highlighting challenges and solutions for medtech companies entering the Chinese market, with tips for streamlining compliance and accelerating approval timelines.
  • Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
10:35 - 11:05
Insight from Japan: Exploring the PMDA and MHL
  • Guide to navigating Japan's approval process
  • Practical examples of regulatory pathways for medical devices in Japan, including product registration, clinical trials, and post-market requirements
  • Case studies showcasing successful strategies for compliance with PMDA and MHLW regulations, along with insights into overcoming common challenges in the Japanese market
  • Ed Woo - Regulatory Consultant, Independent
09:00 - 09:05
Chairperson Remarks
  • Helena Ziert - Account Manager Medical & Health Services, TÜV SÜD
09:05 - 09:35
Are We Ready to Move Beyond Animal Testing?
  • Current state-of-play for animal testing in medical device safety evaluations
  • The three-basket framework for non-animal-based test methods
  • Global efforts to encourage implementation of new approach methodologies in various sectors
  • Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter
09:35 - 10:20
Acceptance of In Vitro Testing – Where are we in 2026?
  • Discussing the current landscape of in vitro testing - what is expected in 2026?
  • Exploring how different regions are integrating in vitro testing into their approval processes, with examples of successful adoption.
  • Addressing barriers to widespread acceptance and exploring strategies to further promote in vitro testing in medical device development.
  • Alina Martirosyan - Senior Scientific Manager Toxicology, B Braun
  • Vera Dowling - Senior Principal Biocompatibility Manager, Cardinal Health
  • Malene Nielsen - Senior Biocompatibility Specialist, 3Shape
  • Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter
10:20 - 11:05
Case Study Conversation: In Silico and AI Driven Biocompatibility Assessment
  • Overview of how computational models and artificial intelligence are revolutionizing biocompatibility assessments for medical devices
  • Discussing a real-world example showcasing the application of in silico and AI-driven methods in biocompatibility testing.
  • Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
Showing 1 of 1 Streams
11:05 - 11:35
Morning Break
Showing 3 of 3 Streams
11:35 - 12:05
Case Study Conversation: Clinical evidence for Al/ML devices & diagnostics: Navigating regulatory challenges under the MDR and FDA frameworks
  • Miriana Jlenia Quattromani - Senior Scientific Manager, 3Shape
12:05 - 12:25
Navigating Global Reliance and Collaboration for PMS
  • Addressing obstacles such as data sharing, harmonization of standards, and regional differences, while identifying opportunities for improved efficiency and global alignment.
  • Exploring perspectives on successful global reliance strategies and collaborative efforts in PMS - lessons learned and future directions.
  • Monica Shah - Sr. Director, Clinical Affairs, Intuitive
12:25 - 13:20
Device Post-market Surveillance & Clinical Evidence for Drug-Device Combination Products
  • Device Clinical Evaluation of Drug-Device Combination Products
  • Device Post--market Surveillance of Drug-Device Combination Products
  • Josep Pané - Head of Device and Digital Vigilance and Safety, UCB
  • Anna Amich - Director Device & Digital Safety, AstraZeneca
11:35 - 12:35
(Continued) Insight from Japan: Exploring the PMDA and MHLW
  • Guide to navigating Japan's approval process
  • Practical examples of regulatory pathways for medical devices in Japan, including product registration, clinical trials, and post-market requirements
  • Case studies showcasing successful strategies for compliance with PMDA and MHLW regulations, along with insights into overcoming common challenges in the Japanese market
  • Ed Woo - Regulatory Consultant, Independent
12:35 - 13:20
The ASEAN Regulatory Framework for Medical Devices – Regional Overview
  • Sasikala Thangavelu - Vice President, SOCIETY OF MEDICAL AND BIOLOGICAL ENGINEERING MALAYSIA (MSMBE)
11:35 - 12:05
Presentation: Novel Threshold of Toxicological Concern (TTC) Values for Medical Devices: From Database Development to ISO Standard Integration
  • Taylor Builee - Senior Principal Toxicology Specialist, Solventum
12:05 - 12:35
Case Study Conversation: Chemical Characterization and Toxicological Risk Assessment of Medical Device Materials
  • Background Introduction
  • Basic Concepts of Chemical Characterization
  • Technical Difficulties in Chemical Characterization
  • Case Study of Chemical Characterization
  • Toxicological Risk Assessment
  • Peter Chen - Senior Principal Scientist, Biocompatibility | Medical Devices, Medical Device Testing Center, WuXi AppTec
12:35 - 13:20
Striving For Global Harmonization Within Biocompatibility Testing
  • Exploring obstacles such as regional regulatory differences, varying testing methodologies, and the integration of new technologies.
  • Discussing strategies to achieve further harmonization, including collaboration between stakeholders, adoption of alternative testing methods, and leveraging advancements in in silico and in vitro technologies.
  • Perspectives on cost and resource saving solutions
  • Denver Faulk - Director of Biocompatibility, Sleep & Respiratory Care, Philips
  • Flora Wegener - Lead Scientific Expert Toxicology, Merz Aesthetics
  • Fabian Kriegel - Head of Material Development & Biocompatibility, Carl Zeiss Meditec
Showing 1 of 1 Streams
13:20 - 14:45
Lunch Break
Showing 3 of 3 Streams
14:45 - 15:15
Preparing for Agentic AI Support in Clinical Departments

Agentic AI is entering clinical departments faster than they can integrate it. While vendors promise rapid automation, most pilots underperform because the teams deploying them are often unprepared.

This session focuses on clinical readiness by exploring where agents deliver value today (such as queries and narrative drafting) and where they break. Learn how to successfully adopt AI by focusing on three key layers: a unified data foundation, supervision-first workflows, and audit-survivable governance. The insights will help you:

  • Understand why AI pilots underperform and where current deployments break

  • Optimize data, workflows, and governance to withstand FDA and EU oversight

  • Gain a 4-stage readiness self-assessment you can apply to your team immediately



  • Frank Trautwein - Director Clinical Strategy, MedTech EU, Veeva
15:15 - 15:45
Strategies to Streamline IFUs for Usability and Harmonization
  • Practical approaches to simplify and clarify IFUs
  • Transition to eIFUs
  • Exploring techniques to align IFUs with global regulatory requirements while maintaining consistency and accessibility for diverse user groups.
  • Mariana Reis - Regulatory Affairs & Quality Assurance, C-mo Medical Solutions
14:45 - 15:15
Regulation Strategy for Medical Devices in the GCC Region – Pathways and Pitfalls
  • An overview of the GCC regulatory framework for medical devices
  • Exploring steps for regulatory approval and identifying common obstacles
  • Insights into future regulatory trends and developments in the GCC region
  • Menna Bahr - Regional Regulatory Affairs GCC, Medtronic
15:15 - 15:45
Unlocking Global Access: UK’s Evolving Reliance & Recognition Pathways Accelerating Safe Medical Device Innovation & Adoption
  • The United Kingdom is positioning itself as an open, globally aligned market for medical devices through expanding reliance and recognition routes, including those leveraging assessments from the USA, Canada and Australia. These pathways reduce duplication, support fairer pre‑market access and reinforce the UK’s commitment to international regulatory harmonisation. At the same time, the MHRA has introduced practical improvements that enable faster, more efficient implementation of PMCF studies using real‑world clinical infrastructure.
  • This session will outline how these reforms enhance UK market attractiveness, what manufacturers should expect next, and how regulatory professionals can prepare for the evolving framework.
  • Jessica Auton - Regulatory Affairs Policy & Intelligence Manager, B.Braun
14:45 - 15:15
Case Study Conversation: Impact of Post-Product Launch Changes on Biocompatibility
  • Exploring case-study example of post-launch modification which altered product biocompatibility - lessons learnt and solution insights.
  • Philippe Hasgall - Research Associate Director, Biological Evaluation, Zimmer Biomet
15:15 - 15:45
Exploring Organ On A Chip Technology For Evaluation of Toxicity Responses
  • Malene Nielsen - Senior Biocompatibility Specialist, 3Shape
15:45 - 15:50
Close of MedTech Summit 2026
Day 3 - Wednesday 17th June
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