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
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: