MD&M West, one of the largest medical device conferences in the nation, brings together industry leaders in medical device manufacturing. WuXi AppTec attends MD&M West each year to support medical device manufacturers with preclinical device safety testing.
Working in collaboration with medical device manufacturers, our technical and regulatory experts guide test strategies and a study approach with input on the device and its intended use. Our service offering meets the needs for your device at all stages of the product lifecycle.
Our proven performance, submission success supports medical device manufacturers at any phase. With more than 25 years’ experience, WuXi AppTec technical and regulatory experts leverage their industry experience and extensive product knowledge to develop a customized approach to unique to your device.
Research, Design and Development Phase
Efficacy Studies – Antimicrobial, Cleaning, Disinfection
Biological Evaluations – Extractables/Leachables, Toxicological Risk Assessment, Biocompatibility
Custom Implant and Other Models
Package Testing – Integrity, Accelerated Aging, Simulated Distribution
Validations – Sterility, Cleaning, and Disinfection
Gap Analysis – Design History Files
Regulatory Response and Regulatory Consulting
On Going Testing – Sterility, Radiation Dose Audits, Microbial Identification, EO Residual, Chemistry
Surface Disinfectant Efficacy
Stop by our booth – 1934 – and speak with us about the current preclinical device safety environment and regulatory trends, and to discuss future projects.
Contact us at email@example.com or 651-675-2000 to arrange to meet with our technical and regulatory experts.