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Chemical Characterization of Medical Devices

White Paper


The chemical characterization of materials is an essential aspect of the regulatory review and approval of medical devices in most major markets worldwide.

Manufacturers are encouraged to integrate chemical characterization efforts into the early stage of the device development process to avoid issues that would disrupt time-to-market schedules.

Download the white paper and discover the specifics of the chemical characterization process, the importance in the overall evaluation of medical device safety, and more.

You'll also learn:

  • The importance of the chemical characterization process
  • Assessment of medical devices
  • How to establish chemical information for approval of medical devices
  • Key industry standards that address the chemical characterization process
  • ISO 10993-18 biological evaluation of medical devices
  • Steps to ensure chemical safety of medical devices 

About the WRITER

Christine Laube, Medical Product Expert and Biological/Analytical Testing Specialist at TÜV SÜDChristine Laube

Christine Laube has over 14 years of experience in microbiology testing and the medical device industry. In her current role as Medical Product Expert and Biological/Analytical Testing Specialist at TÜV SÜD, Christine is responsible for technical documentation review of MDR submissions and facilitating biological and chemical testing services.     



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