Testing Services

WuXi AppTec's medical device testing programs are keyed to the goal of ensuring the success of regulatory submission and the continued quality and consistency required for commercialization. In addition to services that ensure a medical device is manufactured, packaged, and sterilized in accordance with GMP guidelines, WuXi AppTec offers the entire range of relevant test modalities used to study the biological safety and biocompatibility of medical devices.

For more detailed information about available testing services, click here to access the Catalog of Testing Services for the Medical Device Industry

The comprehensive menu of testing programs includes:

Toxicology Testing

(In Vivo and In Vitro)
Biocompatibility/Safety Testing

(In Vivo and In Vitro)
All "Tests for Consideration" based on ISO and FDA guidelines. Also testing specifically required for JMHLW submissions.
Orthopedic, Cardiovascular & Custom Implant Studies
All standard animal models, including long-term large animal.
Histology + Pathology
In-house pathologists provide reports for any tissue from pre-clinical laboratory species. Immunohistochemistry also offered.
Raw Material Verification
Testing of incoming materials to verify consistency and safety
Lot Release Testing
Comprehensive menu of services for final product lot release.
Sterilization Validation
Studies for a variety of commercially available sterilization methods.
Microbial Identifications
Process Change Validation
Changes in the manufacturing process are validated to prove equivalency or comparable efficacy.
Chemical Testing
Services for assessing the safety of materials and processing aids.
Inactivation/Clearance Validation
Inactivation or removal studies for virus, bacteria, mycoplasma, yeast, filamentous fungi, DNA and endotoxin.
Package Integrity Testing
Includes shelf-life studies, and package strength & integrity testing.
Cleaning/Sterilization Validation for Reusable Devices
Comprehensive program for evaluating reuse instructions efficacy.
Controlled Environment Monitoring
To help validate, monitor, and ensure integrity of GMP/controlled environments - from laboratory counters to clean rooms to entire manufacturing facilities. Additional services include disinfection process efficacy and efficacy of cleaners/sanitizers.