Combination Product Testing

WuXi AppTec has many years of experience performing both toxicology and implant studies.

For combination products/leachables, in particular, performing the toxicology and implant testing within one study is faster, more robust and more cost effective.

Plus, the combined study meets ISO 10993 Part 6 and Part 11, providing valid data for submission to the FDA and other regulatory agencies.

TI Experience

Approaching 50 completed TI studies.
More than two dozen different companies have contracted with WuXi AppTec for these studies.
Multiple products have already received regulatory approval.

Program Features

Testing is custom designed with the sponsor for each test article.
Program results meet all ISO/FDA requirements and have been
internationally accepted.
Senior staff have extensive experience in the area of medical device
tissue responses and toxicology.
In-house resources include board-certified pathologist and toxicologist
dedicated to the program.
Regulatory and consulting services available to support sponsors.