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

services for
medical devices

A long-time leader in the medical device industry, WuXi AppTec has the expertise, experience and integrated services to speed your product development process and help ensure successful regulatory submissions worldwide.

Expertise

WuXi AppTec’s scientists are highly proficient in a broad range of competencies – from device-based chemistry to microbiology to in-vitro modeling and in-vivo surgical methods. And our in-house industry experts stay abreast of global regulations and can design programs to meet the specific requirements for any of the guidance bodies.

Experience

For 20 years WuXi AppTec has provided state-of-the-art services for medical devices across their entire lifecycle. Specialized programs have been provided in a full spectrum of product areas, including:

Implants Cellular products
Stents Tissue-based devices
Orthopedics Reusable devices
Wound care Single-use devices
Uterine devices Endoscopic devices
Suture material Cardiovascular devices
Drug delivery Natural products
Human cells Anti-infectives

Integrated Solutions

Our comprehensive menu of testing allows us to provide services at all stages of a medical device’s product life cycle. And we work with you to combine available services into studies and programs that are designed to exactly fit your needs – decreasing the time and costs associated with getting a product from development to regulatory submission to commercial release.

Catalog of Services for Devices & Combo Products

 

services-for-medical-devicesSECTIONS

Introduction
Includes an overview of WuXi AppTec and
a quick guide to working with us.

A. Biocompatibility
B. Chemistry
C. Microbiology
D. Antimicrobial
E. Package Testing
F. Validations:  Sterilization • Reprocessing