15 - 18 June 2026
JW Marriott Hotel Berlin, Berlin, GermanyAttend In-Person or 100% DigitallyMedTech Summitabout eventkeyboard_arrow_right
Clinical Evaluations & PMS - Day 4
Global Markets - Day 4
Biocompatibility - Day 4
09:00 - 10:30
China’s Regulatory Pathways for Medical Devices: The NMPA System Explained
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)
09:00 - 09:45
Case Study Conversation: ISO/ DIS 18969
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
12:15 - 12:45
Spotlight Presentation Opportunity
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
10:15 - 11:00
Case Study Conversation: In Silico and AI Driven Biocompatibility Assessment
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
08:55 - 09:00
Chairperson Remarks
Chairperson Remarks
12:30 - 13:15
The ASEAN Regulatory Framework for Medical Devices – Regional Overview
The ASEAN Regulatory Framework for Medical Devices – Regional Overview
Sasikala Thangavelu - Medical Devices Regulatory Consultant, World Health Organization
15:55 - 16:25
How To Use The Weight Of Evidence Argument - When Tests Are Not Straight Forward?
How To Use The Weight Of Evidence Argument - When Tests Are Not Straight Forward?
11:30 - 12:15
Case Study Conversation: Clinical evidence for Al/ML devices & diagnostics: Navigating regulatory challenges under the MDR and FDA frameworks
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
14:40 - 15:25
Navigating Global Reliance and Collaboration for PMS
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 - Director, Clinical Affairs, Medical Science, Intuitive
12:30 - 13:15
Striving For Global Harmonization Within Biocompatibility Testing
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
09:30 - 10:15
Acceptance of In Vitro Testing – Where are we in 2026?
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
10:30 - 11:00
Insight from Japan: Exploring the PMDA and MHL
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
14:40 - 15:25
Regulation Strategy for Medical Devices in the GCC Region – Pathways and Pitfalls
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
15:55 - 16:25
Low Risk Device Case Study – Thinking Outside The Box
Low Risk Device Case Study – Thinking Outside The Box
15:25 - 16:10
Presentation: Medical Device Regulation Across LATAM – Challenges & Opportunities
Presentation: Medical Device Regulation Across LATAM – Challenges & Opportunities
11:30 - 12:00
Presentation: Novel Threshold of Toxicological Concern (TTC) Values for Medical Devices: From Database Development to ISO Standard Integration
Presentation: Novel Threshold of Toxicological Concern (TTC) Values for Medical Devices: From Database Development to ISO Standard Integration
Taylor Builee - Senior Principle Toxicology Specialist, Solventum
12:45 - 13:15
Device Post-market Surveillance & Clinical Evidence for Drug-Device Combination Products
Device Post-market Surveillance & Clinical Evidence for Drug-Device Combination Products
- Addressing unique complexities in monitoring and evidence collection for combination products
- Examples of successful post-market surveillance strategies and clinical evidence generation
Josep Pané - Head of Device and Digital Vigilance and Safety, UCB
10:15 - 11:00
Case Study Conversation: Diving into ISO 14155
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
12:00 - 12:30
Spotlight Presentation Opportunity
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
09:45 - 10:15
Spotlight Presentation Opportunity
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
15:25 - 15:55
Mastering PFAS Reporting – Synergising US & EU
Mastering PFAS Reporting – Synergising US & EU
- Understanding the regulatory landscape for PFAS reporting in the US and EU, including key differences and commonalities
- Exploring approaches to align PFAS reporting practices - highlighting lessons learned and actionable strategies for compliance.
14:40 - 15:25
Case Study Conversation: Impact of Post-Product Launch Changes on Biocompatibility
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.
Ras Viswanadha - Principal Research Scientist, Zimmer Biomet
11:30 - 12:30
(Continued) Insight from Japan: Exploring the PMDA and MHL
(Continued) 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 - 09:30
Demystifying Hemocompatibility and Highlighting Key Revisions in ISO 10993-4
Demystifying Hemocompatibility and Highlighting Key Revisions in ISO 10993-4
Highlighting the latest updates in the standard, including new testing methodologies, risk assessment approaches, and expanded requirements.
Exploring impact of ISO 10993-4 revisions on device development, regulatory compliance, and market readiness.
Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter
15:25 - 15:55
Strategies to Streamline IFUs for Usability and Harmonization
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
MedTech Summit - Clinical Evaluations & PMS - Day 4
09:00 - 09:45
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
09:45 - 10:15
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
10:15 - 11:00
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
11:30 - 12:15
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
12:15 - 12:45
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
12:45 - 13:15
Device Post-market Surveillance & Clinical Evidence for Drug-Device Combination Products
- Addressing unique complexities in monitoring and evidence collection for combination products
- Examples of successful post-market surveillance strategies and clinical evidence generation
Josep Pané - Head of Device and Digital Vigilance and Safety, UCB
14:40 - 15:25
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 - Director, Clinical Affairs, Medical Science, Intuitive
15:25 - 15:55
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
15:55 - 16:25
Low Risk Device Case Study – Thinking Outside The Box
MedTech Summit - Global Markets - Day 4
09:00 - 10:30
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)
10:30 - 11:00
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
11:30 - 12:30
(Continued) 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
12:30 - 13:15
The ASEAN Regulatory Framework for Medical Devices – Regional Overview
Sasikala Thangavelu - Medical Devices Regulatory Consultant, World Health Organization
14:40 - 15:25
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
15:25 - 16:10
Presentation: Medical Device Regulation Across LATAM – Challenges & Opportunities
MedTech Summit - Biocompatibility - Day 4
08:55 - 09:00
Chairperson Remarks
09:00 - 09:30
Demystifying Hemocompatibility and Highlighting Key Revisions in ISO 10993-4
Highlighting the latest updates in the standard, including new testing methodologies, risk assessment approaches, and expanded requirements.
Exploring impact of ISO 10993-4 revisions on device development, regulatory compliance, and market readiness.
Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter
09:30 - 10:15
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
10:15 - 11:00
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
11:30 - 12:00
Presentation: Novel Threshold of Toxicological Concern (TTC) Values for Medical Devices: From Database Development to ISO Standard Integration
Taylor Builee - Senior Principle Toxicology Specialist, Solventum
12:00 - 12:30
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
12:30 - 13:15
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
14:40 - 15:25
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.
Ras Viswanadha - Principal Research Scientist, Zimmer Biomet
15:25 - 15:55
Mastering PFAS Reporting – Synergising US & EU
- Understanding the regulatory landscape for PFAS reporting in the US and EU, including key differences and commonalities
- Exploring approaches to align PFAS reporting practices - highlighting lessons learned and actionable strategies for compliance.
15:55 - 16:25
How To Use The Weight Of Evidence Argument - When Tests Are Not Straight Forward?