U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing


Medical Device Product Packaging: Validation and Regulatory Consulting Support

In November 2017, FDA released their final guidance on unique device identifier..

WuXi AppTec Director of Analytical Chemistry to speak in Scientific Session at Society of Toxicology

The Annual Meeting for the Society of Toxicology, SOT 2018, kicks off..

WuXi AppTec: Partner for Reprocessing

With a device that will undergo reprocessing, there are critical steps an..

What to do next? Toxicological Risk Assessment of Analytical Chemistry Data

A biological evaluation is a weight of evidence. It consists of materials..

Reprocessing Studies: Cleaning Instructions Validation and Predicate Devices

When the FDA releases a guidance to the industry, such as the..

Extractables / Leachables Studies: Recommendations and Considerations for Medical Device Pre-submission Testing

Demand for extractables and leachables studies increases as industry and regulatory bodies..