Register for our Live Webinar:
Thursday, June 11, 2026 | 11:00 am EDT | 8:00 am PDT | 5:00 pm CET

Event Overview

With increasing emphasis from regulatory agencies on chemical characterization of medical devices under ISO 10993-18, it is important to ensure that a risk-based strategic approach is jointly developed by an experienced toxicologist and analytical laboratory. A proper study design should balance regulatory requirements, toxicological objectives, and practical laboratory considerations. For complex device materials—such as human- or animal-derived tissues, hydrogels, silicone implants, absorbables, and similar materials—the study design may present unique challenges. Devices composed of complex materials often require a highly individualized and nuanced study design. Regulatory success can be greatly improved when these programs are both developed and executed through close collaboration between the toxicologist and the extractables laboratory.

During this webinar, we will discuss:

  • Toxicological considerations for the chemical characterization of tissues and other complex materials
  • Principles of study design and risk-based approaches for challenging chemical characterizations
  • Examples of individualized study plans for a variety of complex materials, developed in collaboration with a toxicologist and successfully applied in regulatory submissions

Presenters:

Leela_marketo.jpg
 Leela Chapman, B.S.
Manager
Eurofins Medical Device Services
As Manager for Eurofins Medical Device Services, Leela Chapman is responsible for designing and overseeing ISO 10993-18 chemical characterization studies and peripheral analytical chemistry supporting regulatory medical device fillings and investigational studies. Leela has nine years of experience in managing extractables studies supporting the medical device and pharmaceutical industries. She holds a Bachelor of Science in Chemistry from Truman State University.
Kim E.jpg
 Kimberly Ehman, Ph.D., DABT
Head of Regulatory Toxicology
Eurofins Medical Device Services
As Head of Regulatory Toxicology, Kimberly Ehman leads the biocompatibility consulting and toxicological risk assessment services for Eurofins Medical Device Services North America. She has more than 20 years of toxicology and medical device experience, with expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems.

Prior to joining Eurofins, she was the Director of Regulatory Toxicology and Consulting at WuXi AppTec and has also held positions at Altria Client Services (Head of Regulatory Toxicology), Toxicology Regulatory Services (Consulting Toxicologist and Program Manager), and RTI International (Research Toxicologist for Developmental and Reproductive Toxicology and Neurotoxicology). She earned her PhD from McGill University in Montréal, Canada, and conducted her postdoctoral research at the US EPA, with a focus on developmental neurotoxicology. She has been a Diplomate of the American Board of Toxicology since 2009 and an active member of the Society of Toxicology (SOT) since 2005 and the American College of Toxicology (ACT) since 2010. She is currently the VP-elect for the Medical Device and Combination Product Specialty Section (MDCPSS) of SOT and serves as an expert on several US working groups for the ISO 10993 series of standards, including ISO 10993-1 (Evaluation and testing within a risk management process), ISO 10993-3 (Tests for genotoxicity, carcinogenicity, and reproductive toxicity), and ISO 10993-17 (Toxicological risk assessment of medical device constituents).
Todd_marketo.jpg Todd Stark, Ph.D. (Moderator)
Regional Sales Manager
Eurofins Medical Device Services
As Regional Sales Manager for Eurofins Medical Device Services, Todd Stark, Ph.D., works with clients to identify and utilize the full breadth of testing services offered by Eurofins. Dr. Stark has over 25 years of experience with contract services in both the pharma and medical device industries. Todd holds a Ph.D. in Organic Chemistry from UCLA.
Register for our On Demand Webinar

With increasing emphasis from regulatory agencies on chemical characterization of medical devices under ISO 10993-18, it is important to ensure that a risk-based strategic approach is jointly developed by an experienced toxicologist and analytical laboratory. A proper study design should balance regulatory requirements, toxicological objectives, and practical laboratory considerations. For complex device materials—such as human- or animal-derived tissues, hydrogels, silicone implants, absorbables, and similar materials—the study design may present unique challenges. Devices composed of complex materials often require a highly individualized and nuanced study design. Regulatory success can be greatly improved when these programs are both developed and executed through close collaboration between the toxicologist and the extractables laboratory.

During this webinar, you will learn:

    • Toxicological considerations for the chemical characterization of tissues and other complex materials
    • Principles of study design and risk-based approaches for challenging chemical characterizations.
    • Examples of individualized study plans for a variety of complex materials, developed in collaboration with a toxicologist and successfully applied in regulatory submissions


Presenters:
Leela_marketo.jpg
 Leela Chapman, B.S.
Manager
Eurofins Medical Device Services
Kim E.jpg Kimberly Ehman, PhD
Head of Regulatory Toxicology
Eurofins Medical Device Services
Todd_marketo.jpg Todd Stark, Ph.D. (Moderator)
Regional Sales Manager
Eurofins Medical Device Services