Biocompatibility Testing for Medical Devices
The complexity involved in choosing the right biocompatibility testing for medical devices has substantially increased over recent years. In order to successfully move medical devices to market, it is crucial to have experts available to help develop complete submission packages, and to offer the right advice for biocompatibility testing. Industry-recognized scientists at WuXi AppTec are experienced in providing expert guidance to medical device and combination product manufacturers in designing specific biocompatibility programs for their submissions to regulatory agencies worldwide.
WuXi AppTec has a comprehensive menu of biocompatibility testing services for medical devices. The testing services offer a variety of customization capabilities that focus on customizing standard protocols to fit specific medical device product development needs. The biocompatibility program also offers on-site ancillary labs including histopathology and clinical pathology, and a technical staff with experience that comes from performing thousands of biocompatibility assays. All tests are fitted to the ISO/FDA guidelines, and each one features multiple modalities to simulate clinical relevance and achieve data of the highest possible quality.
In-vitro Testing Services include:
- Cytotoxicity
- Hemocompatibility
- Genotoxicology
In-vivo Testing Services Include:
- Irritation
- Sensitization
- Systemic Toxicity
- Implantation
- Sub-chronic and Chronic Toxicity
For more about the different types of testing services that WuXi AppTec has to offer, download the datasheet.