15 - 18 June 2026
JW Marriott Hotel Berlin, Berlin, GermanyAttend In-Person or 100% DigitallyMedTech Summitabout eventkeyboard_arrow_right
Clinical Evaluations & PMS - Day 3
Global Markets - Day 3
Biocompatibility - Day 3
Roundtables - Day 3
Future Regulatory Leaders Link-up
15:40 - 16:30
Roundtables - Rotation 2
Roundtables - Rotation 2
| Table 1: Clinical Evaluations | Question Circle | Table 5: Biocompatibility | Question Circle |
| Table 2: Clinical Evaluations | Navigating equivalence criteria | Table 6: Biocompatibility | ISO-10993-1 |
| Table 3: PMS | Question Circle | Table 7: Global Markets| Question Circle |
| Table 4: PMS | Resource & cost constraints | Table 8: Global Markets | Global submissions |
Adam Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Philips
Monica Shah - Director, Clinical Affairs, Medical Science, Intuitive
Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
10:15 - 11:00
US Political Climate - Steering Through Supply Chain Turbulence
US Political Climate - Steering Through Supply Chain Turbulence
- Analysing the impact of the current US political climate on the MedTech regulatory landscape
- Discussing strategies for navigating supply chain disruptions and ensuring regulatory compliance amidst geopolitical and economic challenges - what new perspectives are there to supply chain management?
- How can we future-proof? What considerations need to be made in 2026 to stay ahead?
Rene Zoelfl - Senior Director, Global Industry Advisor Life Science, PTC
10:15 - 11:00
Life cycle approach: Re-shaping Biological Evaluation Within the Total Device Lifecycle
Life cycle approach: Re-shaping Biological Evaluation Within the Total Device Lifecycle
- How does biocompatibility converge with clinical evaluations and PMS in 2026?
- Diving into how a life cycle approach integrates biological evaluation into every stage of the medical device lifecycle, from design to post-market surveillance.
- Discussing strategies for aligning biological evaluation with evolving regulatory expectations and risk management practices.
Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group
12:15 - 12:45
Spotlight Presentation Opportunity
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
08:55 - 09:00
Chairperson Remarks
Chairperson Remarks
15:20 - 15:40
Refreshment Break
Refreshment Break
09:00 - 09:30
Looking to the Future of Biological Safety Evaluations
Looking to the Future of Biological Safety Evaluations
Ron Brown - Toxicologist, Risk Science Consortium
09:00 - 09:45
Navigating Medical Device & IVD Regulation in Emerging Market Opportunities
Navigating Medical Device & IVD Regulation in Emerging Market Opportunities
- Strategies for navigating diverse regulatory frameworks while ensuring compliance and market access
- Dealing with infrastructure gaps - how to leverage local partnerships and adapting to regional requirements to capitalize on emerging market growth
- IP risk and ensuring protection
- Sharing perspectives on cost-reduction
Goran Adburrahman - Senior IVD Product Specialist, TÜV Rheinland
Ed Woo - Regulatory Consultant, Independent
Menna Bahr - Regional Regulatory Affairs GCC, Medtronic
11:30 - 12:00
US Perspective on 10993-1: FDA’s Approach To A Risk-based Mindset
US Perspective on 10993-1: FDA’s Approach To A Risk-based Mindset
- Understanding the FDA’s risk-based approach to ISO 10993-1 and its application in biological evaluation for medical devices.
- Exploring how manufacturers can align with FDA expectations by integrating risk management into their biocompatibility assessments.
Sarah Belperain - Senior Biocompatibility Specialist/Toxicologist, Argon Medical Devices
11:30 - 12:15
Proactive PMS – How Is This Defined in 2026?
Proactive PMS – How Is This Defined in 2026?
- Exploring innovative tools, technologies, and methodologies shaping the future of PMS to ensure compliance and improve patient safety.
- Perspectives on regulatory expectations and best practices for implementing a forward-thinking PMS strategy.
Fayez Abou Hamad, MD - PMS & Vigilance Expert Consultant – Pharmacist, Terumo
12:45 - 13:15
UK & PMS: Looking Back and Looking Ahead
UK & PMS: Looking Back and Looking Ahead
- 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, MRHA
10:15 - 11:00
Clinical Evaluation Updates for Recertification: Leveraging 5 Years of PMS Data
Clinical Evaluation Updates for Recertification: Leveraging 5 Years of PMS Data
- Examine the latest updates in clinical evaluation requirements for medical device recertification, focusing on leveraging post-market surveillance (PMS) data.
- Discuss strategies for effectively utilizing 5 years of PMS data to demonstrate ongoing compliance and device safety.
- Insights into best practices for integrating PMS findings into clinical evaluation reports to streamline the recertification process.
Rina Sant - Associate Director, Regulatory Affairs Post-Market Management, Abbott
11:30 - 12:00
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
09:30 - 10:15
ISO 10993-1 2026 Updates: Risk Management as the Backbone of Biological Evaluation
ISO 10993-1 2026 Updates: Risk Management as the Backbone of Biological Evaluation
- What has changed in practice since the 2025 update?
- How do regulators assess biological evaluation reports now?
- Exploring common pitfalls and come-backs
Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter
09:45 - 10:15
Design For Registration - A Principle for Global Regulatory Strategy
Design For Registration - A Principle for Global Regulatory Strategy
Michael King - Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), IQVIA
12:30 - 13:15
The Intersection of 10993-1 & 10993-1 – Chemical Characterisation & Toxicological Risk Assessment Deep Dive
The Intersection of 10993-1 & 10993-1 – Chemical Characterisation & Toxicological Risk Assessment Deep Dive
- Diving into the critical connection between ISO 10993-1 and ISO 10993-17, focusing on chemical characterization and toxicological risk assessment
- Exploring methodologies for integrating chemical data with toxicological evaluations to ensure comprehensive biological safety assessments.
- Discussing practical insights into aligning chemical characterization and risk assessment processes with regulatory expectations.
14:30 - 15:20
Roundtables - Rotation 1
Roundtables - Rotation 1
| Table 1: Clinical Evaluations | Question Circle | Table 5: Biocompatability | Question Circle |
| Table 2: Clinical Evaluations | Leveraging real-world evidence | Table 6: Biocompatibility | Emerging Materials and Technologies |
| Table 3: PMS | Question Circle | Table 7: Global Markets | Question Circle |
| Table 4: PMS | Future of recertification | Table 8: Global Markets | Scaling operations |
Adam Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Philips
Monica Shah - Director, Clinical Affairs, Medical Science, Intuitive
Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
12:00 - 13:15
Designing for Approval: Meeting FDA Expectations in Device Development
Designing for Approval: Meeting FDA Expectations in Device Development
- Outlining key FDA expectations for medical device design and development, focusing on aligning innovation with regulatory requirements.
- Discussing strategies for integrating regulatory considerations early in the design process to streamline approval pathways.
- Practical take-aways for best practices to balancing device functionality, safety, and compliance to meet FDA standards effectively.
Steve Weber - Assistant Professor, The Johns Hopkins School of Medicine
12:00 - 12:30
When 10993-17 Is Not Sufficient – Building Alternative Toxicological Justifications
When 10993-17 Is Not Sufficient – Building Alternative Toxicological Justifications
- Exploring scenarios where ISO 10993-17 may not fully address toxicological risk assessment needs for medical devices.
- Looking at how to develop alternative toxicological justifications using scientific data, literature, and risk-based approaches.
Vera Dowling - Senior Principal Biocompatibility Manager, Cardinal Health
14:30 - 15:20
Future Regulatory Leaders Link-up
Future Regulatory Leaders Link-up
Unlock Your Potential in Medical Device Regulatory Affairs:
Learn directly from seasoned regulatory leaders who have navigated successful career paths in the medical device industry. Discover the key decisions, pivotal moments, and strategic moves that propelled them to senior positions.
09:00 - 09:45
The Future of Clinical Evidence in the Medical Device Lifecycle
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 Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Philips
Tonia Jeiter - Senior Manager Clinical Evaluation and Clinical Lifecycle Management, Alcon
MedTech Summit - Clinical Evaluations & PMS - Day 3
09:00 - 09:45
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 Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Philips
Tonia Jeiter - Senior Manager Clinical Evaluation and Clinical Lifecycle Management, Alcon
09:45 - 10:15
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
10:15 - 11:00
Clinical Evaluation Updates for Recertification: Leveraging 5 Years of PMS Data
- Examine the latest updates in clinical evaluation requirements for medical device recertification, focusing on leveraging post-market surveillance (PMS) data.
- Discuss strategies for effectively utilizing 5 years of PMS data to demonstrate ongoing compliance and device safety.
- Insights into best practices for integrating PMS findings into clinical evaluation reports to streamline the recertification process.
Rina Sant - Associate Director, Regulatory Affairs Post-Market Management, Abbott
11:30 - 12:15
Proactive PMS – How Is This Defined in 2026?
- Exploring innovative tools, technologies, and methodologies shaping the future of PMS to ensure compliance and improve patient safety.
- Perspectives on regulatory expectations and best practices for implementing a forward-thinking PMS strategy.
Fayez Abou Hamad, MD - PMS & Vigilance Expert Consultant – Pharmacist, Terumo
12:15 - 12:45
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
12:45 - 13:15
UK & PMS: Looking Back and Looking Ahead
- 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, MRHA
MedTech Summit - Global Markets - Day 3
09:00 - 09:45
Navigating Medical Device & IVD Regulation in Emerging Market Opportunities
- Strategies for navigating diverse regulatory frameworks while ensuring compliance and market access
- Dealing with infrastructure gaps - how to leverage local partnerships and adapting to regional requirements to capitalize on emerging market growth
- IP risk and ensuring protection
- Sharing perspectives on cost-reduction
Goran Adburrahman - Senior IVD Product Specialist, TÜV Rheinland
Ed Woo - Regulatory Consultant, Independent
Menna Bahr - Regional Regulatory Affairs GCC, Medtronic
09:45 - 10:15
Design For Registration - A Principle for Global Regulatory Strategy
Michael King - Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), IQVIA
10:15 - 11:00
US Political Climate - Steering Through Supply Chain Turbulence
- Analysing the impact of the current US political climate on the MedTech regulatory landscape
- Discussing strategies for navigating supply chain disruptions and ensuring regulatory compliance amidst geopolitical and economic challenges - what new perspectives are there to supply chain management?
- How can we future-proof? What considerations need to be made in 2026 to stay ahead?
Rene Zoelfl - Senior Director, Global Industry Advisor Life Science, PTC
11:30 - 12:00
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at niha.singh@informa.com
12:00 - 13:15
Designing for Approval: Meeting FDA Expectations in Device Development
- Outlining key FDA expectations for medical device design and development, focusing on aligning innovation with regulatory requirements.
- Discussing strategies for integrating regulatory considerations early in the design process to streamline approval pathways.
- Practical take-aways for best practices to balancing device functionality, safety, and compliance to meet FDA standards effectively.
Steve Weber - Assistant Professor, The Johns Hopkins School of Medicine
MedTech Summit - Biocompatibility - Day 3
08:55 - 09:00
Chairperson Remarks
09:00 - 09:30
Looking to the Future of Biological Safety Evaluations
Ron Brown - Toxicologist, Risk Science Consortium
09:30 - 10:15
ISO 10993-1 2026 Updates: Risk Management as the Backbone of Biological Evaluation
- What has changed in practice since the 2025 update?
- How do regulators assess biological evaluation reports now?
- Exploring common pitfalls and come-backs
Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter
10:15 - 11:00
Life cycle approach: Re-shaping Biological Evaluation Within the Total Device Lifecycle
- How does biocompatibility converge with clinical evaluations and PMS in 2026?
- Diving into how a life cycle approach integrates biological evaluation into every stage of the medical device lifecycle, from design to post-market surveillance.
- Discussing strategies for aligning biological evaluation with evolving regulatory expectations and risk management practices.
Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group
11:30 - 12:00
US Perspective on 10993-1: FDA’s Approach To A Risk-based Mindset
- Understanding the FDA’s risk-based approach to ISO 10993-1 and its application in biological evaluation for medical devices.
- Exploring how manufacturers can align with FDA expectations by integrating risk management into their biocompatibility assessments.
Sarah Belperain - Senior Biocompatibility Specialist/Toxicologist, Argon Medical Devices
12:00 - 12:30
When 10993-17 Is Not Sufficient – Building Alternative Toxicological Justifications
- Exploring scenarios where ISO 10993-17 may not fully address toxicological risk assessment needs for medical devices.
- Looking at how to develop alternative toxicological justifications using scientific data, literature, and risk-based approaches.
Vera Dowling - Senior Principal Biocompatibility Manager, Cardinal Health
12:30 - 13:15
The Intersection of 10993-1 & 10993-1 – Chemical Characterisation & Toxicological Risk Assessment Deep Dive
- Diving into the critical connection between ISO 10993-1 and ISO 10993-17, focusing on chemical characterization and toxicological risk assessment
- Exploring methodologies for integrating chemical data with toxicological evaluations to ensure comprehensive biological safety assessments.
- Discussing practical insights into aligning chemical characterization and risk assessment processes with regulatory expectations.
MedTech Summit - Roundtables - Day 3
14:30 - 15:20
Roundtables - Rotation 1
| Table 1: Clinical Evaluations | Question Circle | Table 5: Biocompatability | Question Circle |
| Table 2: Clinical Evaluations | Leveraging real-world evidence | Table 6: Biocompatibility | Emerging Materials and Technologies |
| Table 3: PMS | Question Circle | Table 7: Global Markets | Question Circle |
| Table 4: PMS | Future of recertification | Table 8: Global Markets | Scaling operations |
Adam Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Philips
Monica Shah - Director, Clinical Affairs, Medical Science, Intuitive
Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
15:20 - 15:40
Refreshment Break
15:40 - 16:30
Roundtables - Rotation 2
| Table 1: Clinical Evaluations | Question Circle | Table 5: Biocompatibility | Question Circle |
| Table 2: Clinical Evaluations | Navigating equivalence criteria | Table 6: Biocompatibility | ISO-10993-1 |
| Table 3: PMS | Question Circle | Table 7: Global Markets| Question Circle |
| Table 4: PMS | Resource & cost constraints | Table 8: Global Markets | Global submissions |
Adam Klienman - Associate Director, Clinical Compliance Hospital Patient Monitoring, Philips
Monica Shah - Director, Clinical Affairs, Medical Science, Intuitive
Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex
MedTech Summit - Future Regulatory Leaders Link-up
14:30 - 15:20
Future Regulatory Leaders Link-up
Unlock Your Potential in Medical Device Regulatory Affairs:
Learn directly from seasoned regulatory leaders who have navigated successful career paths in the medical device industry. Discover the key decisions, pivotal moments, and strategic moves that propelled them to senior positions.