Chemical Characterization of Medical Devices

ENSURING chemical SAFETY OF MEDICAL DEVICES

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.

Complete the form to download the white paper.

Download the white paper to 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

Technical Advisor, TÜV SÜD 
Christine Laube, a microbiologist and cell biologist, has over 14 years of experience in medical device reprocessing validation and antimicrobial and pharmaceutical testing. She has extensive expertise in MDR technical documentation review expertise and supports TÜV SÜD’s biological safety testing services. Christine collaborates with customers to navigate regulatory requirements, ensuring compliance and the safety of their medical devices.