Agenda - Day Three – 18 June 2025

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Biocompatibility for Medical Devices - Day 1

08:00 - 08:10

Chairperson’s Opening Remarks : Biocompatibility for Medical Devices

Beau Rollins - Head of Biocompatibility, ConvaTec

08:10 - 08:55

ISO 10993-1: What’s Really Going On?

What does the latest revision to ISO 10993-1 really mean for you?

What are the biggest changes between versions?
What do manufacturers and testing facilities need to do differently?

Examples of various product cases on how changes can affect the biological evaluation of already marketed devices and devices under development.

Jeannette van Loon, PhD - CEO at Medical Device Project B.V, Member, ISO TC 194 WG1

08:55 - 09:40

A Focused Look: 10993-1 and Genotoxicity

One of the key revisions for –1 centres around genotoxicity, but what does this mean?

Which groups is this endpoint applicable to now?
Why has this change materialised?
What does this increased evaluation mean for wider public health?

Best practices for applying genotoxicity to those who have not previously

Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter

09:40 - 10:10

Evaluating Biological Safety for US Submissions – Learnings from the Field

Michael Thaller - Product Developer & Biocompatibility & Product Safety Specialist, Carl Zeiss Meditec AG

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Biocompatibility for Medical Devices - Day 1

11:10 - 11:55

The Paper Anniversary: 1 Year on since ISO 10993-17

With –17 having been in place for 1 year, what are industry’s first experiences of adhering to the standard?
- Are there differences in EU and FDA acceptance?
- Can we expect further alignment?
- Which parts are causing the most confusion?
- Possible solutions to ease working under -17

Michelle Kelly - Toxicologist, NAMSA

11:55 - 12:40

ISO 10993-18: Current State and Critical issues in Chemical Characterization of Medical Devices from the Perspectives of Science, International Standards, and Regulations

Jianwei Li - Chemical Characterization Consultant and Technical Writer, Chemical Characterization Solutions, LLC

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Biocompatibility for Medical Devices - Day 1

14:10 - 14:15

Chairperson’s Afternoon Remarks: Biocompatibility for Medical Devices

Beau Rollins - Head of Biocompatibility, ConvaTec

14:15 - 14:45

Integrated Non-targeted Screening and Targeted Analysis Approach To Improve Accuracy of Toxicological Risk Assessment For Orthopedic Implant Leachates.

What is chemical characterization?
Semi quantitative vs quantitative analysis
Substance Identification Challenges
Findings

Daniel Andreas Klauser - Medical Device Safety Specialist MDR, Zimmer Biomet

14:45 - 15:15

ISO 8250 Cleanliness of Medical Devices: Characterisation of Contamination for the Biological Evaluation of Medical Devices

Boopathy Dhanapal - Convener of ISO/TC 194 WG 18, Independent Consultant

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Biocompatibility for Medical Devices - Day 1

16:15 - 17:00

EtO Sterilization Updates: EU vs US

What are these updates?
Are there any impacts for manufacturers?
Do biological evaluations and modalities need to be revised?
Which alternatives are available, and should we consider using them?

Beau Rollins - Head of Biocompatibility, ConvaTec

17:00 - 17:45

Panel: Understanding Global Acceptance: In Vitro vs In Vivo

As the debate rumbles on, where are we with global acceptance of in vitro vs in vivo testing?
- Has the US moved more towards acceptance?
Industry implications
- Can industry streamline testing methods to be applicable for both regions?
- Which areas commonly cause issues with submissions?
  - Practices to overcome

Emma Pedersen - Senior Scientist Biocompatibility, Mölnlycke Health Care
Vera Dowling - Senior Principal Biocompatibility Manager, Cardinal Health
Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex

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Day Three – 18 June 2025Wednesday, 18 June 2025 - CEST Time Zone

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