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

Posted by Rachel Callender on February 19, 2019

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:

Read the Article

If you have questions or want to discuss your MDR & ISO 10993-1 journey, contact us immediately!

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Read more about ISO 10993-1 and MDR regulations below:

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

Pre-clinical medical device testing under ISO 10993-1 and the MDR

 

  

Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR