Medical Design Briefs online recently featured an article written by Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi AppTec, expert in re-writing ISO 10993-18 as part of TC 194 / Working Group 14.

“Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1” shares important information that medical device OEM’s need to know about the impending regulatory updates and submission deadlines.

In this article you will learn:

  • The new ISO 10993-1 and MDR testing requirements
  • How to perform a gap analysis
  • The proper sequence of preclinical device testing
  • The importance of chemical characterization and when to do it
  • Questions to ask when vetting a CRO

Read the Article Here

If you have questions or want to discuss your MDR & ISO 10993-1 journey, contact us! Read more about ISO 10993-1 and MDR regulations:

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Preclinical medical device testing under ISO 10993-1 and the MDR