Medical Device Contract Manufacturing | Medical Device / Product Biocompatibility Testing Services
Your partner in medical device and combination product development
Toxikon is well known throughout the global medical device industry, and we have been proudly meeting the development challenges of component, raw material, and finished device manufacturers for more than 30 years. While outsourced medical device testing has increased along with the proliferation of new and increasingly complex medical devices, Toxikon continually stays ahead of the curve for it clients and partners thanks to its team expertise and capabilities.
Toxikon is an active member of the Medical Device Manufacturing Association and Mass Medic, the Massachusetts Medical Device Council. The device section of our Website contains technical information on the variety of services we offer for medical device development. These offerings include analytical, biocompatibility, biomaterial, extractables and leachables, genetic and molecular, microbiology, and cell culture, and reproductive and developmental toxicology testing.
In addition, Toxikon offers these specialized capabilities:
Substantial models for comprehensive evaluation of various cardiovascular, gastrointestinal, ocular, orthopedic and neurological devices;
Custom studies for devices for drug delivery applications to treat wounds, as well as gastroenterological, urologic, respiratory, and other disorders;
Advanced, high-capacity facilities with modern surgical suites and on-site housing for small and large species;
A full array of specialized imaging, measurement and monitoring equipment.
With regulatory agencies in the U.S. and abroad, it is important to partner with a CRO that can guide you through the preclinical regulatory landscape to reach the clinical stage and, ultimately, to market. Our study directors have a deep understanding of the issues medical device makers face, and that’s just one aspect of Toxikon’s service offerings.
Our facilities include instrumentation for analytical and bioanalytical, biocompatibility, biomaterial, extractables and leachables, genetic and molecular, microbiology, and mammalian, and reproductive and developmental toxicology testing.
The Development Path
RESOURCESDownload Hemocompatibility:Preclinical Biological Evaluation of Medical Devices for Interaction with Blood Download Reprocessing Medical Devices: Approaches and Considerations for Manual Cleaning Validations Here