MDR & ISO 10993-1: How to Navigate Preclinical Device Testing

MDR & ISO 10993-1: How to Navigate Preclinical Device Testing

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:

How to Plan for EU MDR So You Can Sleep at Night

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