Medical Device Services
Integrated Services Speeding Products from Concept to Commercialization
WuXi AppTec's services ensure that a medical device is manufactured, packaged, and sterilized in accordance with GMP guidelines. In addition, WuXi AppTec offers all the relevant test modalities used to study the biological safety and biocompatibility of medical devices.
Implantable Devices
Tissue-Based Products
Combination Products
Cardiovascular Products
Orthopedic Products
Neurological Products
Reusable Devices
Research Devices/Materials
Testing services (GLP- and GMP-compliant) include: Custom device performance and materials testing • Complete biocompatibility testing per FDA/ISO 10993 and JMHLW (Japan) • Toxicology discovery and safety studies • Product validation programs for all commercially available sterilization methods • Lot release, raw material and vendor qualification testing • Complete testing services for controlled environments.
For processed tissue and tissue-based products, WuXi AppTec provides the nation's most comprehensive program including safety and lot release testing such as osteoinductivity (in vitro and in vivo), as well as custom studies such as viral inactivation studies and process change validations.
GMP/GTP Manufacturing Services
WuXi AppTec's single-source platform also provides GMP/GTP manufacturing services and aseptic processing for specialty device, combination and tissue-based products in environmentally controlled laboratories - from pilot projects to commercial-scale production.