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...

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ISO 10993-1: The Importance of Chemical Characterization

Think recent regulatory changes to ISO 10993-1 are impacting biocompatibility programs? Think again! Our Director of Analytical Chemistry, and International Delegate for ISO 10993 part 18, Sandi...

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A Regulatory Consultant's Guide to ISO 10993 Updates Webinar

With changes to ISO 10993, chemical testing is more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing...

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A Risk-Based Approach to Medical Device Testing Starts with Extractables and Leachables

As industry and regulatory bodies adopt the ISO 10993 Risk-Based Approach to Biological Evaluations, the demand for materials characterization studies increases.

And just as materials...

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WuXi AppTec Joins Industry Leaders on Extractables & Leachables at E&L USA

WuXi AppTec returns to E&L USA this May in Bethesda, MD.

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