Chemical Characterization of Medical Devices - Insights from the Testing Lab

Chemical characterization is a critical foundation for demonstrating the biological safety of medical devices and supporting Toxicological Risk Assessments (TRAs). As regulations and standards continue to evolve, manufacturers face increasing expectations around the quality, relevance, and documentation of chemical characterization data used during medical device development. 

In this educational webinar, Jordan Gunn, PhD, a chemist at TÜV SÜD, shares practical insights from the testing laboratory. The session focuses on how chemical characterization testing is planned, performed, and reported to support TRA and biological evaluation, drawing on standards-driven laboratory experience. 

Grounded in ISO 10993 standards, laboratory best practices, and real-world analytical testing, this webinar can help manufacturers understand how robust chemical data supports medical device safety and submission readiness. 
  

Key topics: 

• How US and EU regulations and international standards interact with one another and evolve over time 
• The role of chemical characterization in the biological evaluation of medical devices 
• Practical considerations for chemical characterization under ISO 10993-18 
• How early planning of chemical characterization activities can support more efficient development timelines
      

Why Chemical Characterization Matters 

Chemical characterization provides essential information about substances that may leach from medical devices under clinical or intended use conditions. When appropriately designed and executed, this testing supports: 

• Identifying chemical composition, extractables, and leachables 
• Generating data used to conduct TRA’s and perform biological evaluations 
• Determining which, if any, biological tests are warranted or required 
• Aligning with regulations and standards for the biological safety of medical devices 

Understanding how laboratory testing decisions impact biological safety justifications and TRA outcomes is key to building a strong safety rationale for medical devices.
   

Speaker: 

Jordan Gunn, PhD 
Chemist, TÜV SÜD
Jordan Gunn, PhD, is a chemist with over 10 years of experience in chemical characterization and analytical testing for medical devices and pharmaceuticals, including extractables and leachables testing using LC-MS, GC-MS, and HS-GC-MS. He is an NIH fellow, having earned an individual pre-doctoral fellowship for his graduate studies in drug discovery. 

Why Attend TÜV SÜD’s Webinar 

• Learn directly from an independent testing laboratory expert 
• Gain clarity on how chemical characterization is conducted and used to perform TRA’s and justify biological safety. 
• Better understanding of ISO 10993-18 aligned testing approaches 
• Strengthening collaboration between R&D, QA, and testing teams 
• Ask technical questions in a neutral, educational environment 

Disclaimer: This webinar is for educational purposes only. TÜV SÜD does not provide regulatory consulting services or regulatory decisions and does not represent regulatory authorities.