ISO 10993-18 Updates: What You Need to Know

The International Organization for Standardization (ISO) released long-anticipated changes to standard 10993-18 on January 15, 2020. Updates will impact chemical characterization and toxicological...

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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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Our All-Inclusive Approach to Microbial Identification

WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories.

Our clients come to us when a microbial excursion has...

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Environmental Monitoring Supports a Risk-Based Approach to Manufacturing Control

Robust Environmental Monitoring Program includes information to support process controls through sample collection, microbial testing and trending data. 

Environmental monitoring is one way a...

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Radiation Sterilization: Verifying Dose Survivors

A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit...

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Radiation Sterilization: Product Bioburden and Verification Dose

WuXi AppTec supports the best practice of monitoring bioburden quantitatively and qualitatively to ensure the established radiation dose is valid.

For many medical device manufacturers, radiation...

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Product Adoption for Sterilization Validation

When your product has had a material change, a component added, or a new size developed, does this necessarily mean you must complete the sterilization validation of each?

There is another...

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Poor Extraction Methods Can Impact Study Results

When planning a cleaning validation study for your medical device, a validated extraction method is one requirement.

The purpose of an extraction process is to recover any residual soils from the...

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