Choosing the correct path for biocompatibility testing has become more complex than ever. Having knowledgeable experts on your team to help develop complete submission packages is crucial to successfully moving your product to market.
For 20 years, the experienced, knowledgeable scientists at WuXi AppTec have provided medical device and combination product manufacturers with expert guidance in designing specific biocompatibility programs for submissions to regulatory agencies worldwide, including US FDA, EU, JMHLW and Korea.
Our comprehensive menu of services – which includes all the tests related to the ISO/FDA guidelines – features multiple modalities to simulate clinical relevance and achieve data of the highest possible quality.
In-vitro testing services include:
cytotoxicity, hemocompatibility, and genotoxicology.
In-vivo testing services include:
irritation, sensitization, systemic toxicity, implantation, and subchronic and chronic toxicity.
Biocompatibility Program Features
Supporting WuXi AppTec’s biocompatibility testing program is an infrastructure built on years of being a leader in the industry and at the forefront of cutting-edge biocompatibility testing.
- Regulatory Expertise: Industry-recognized experts who actively participate in regulatory committees and transfer that knowledge into program designs.
- Customization Capabilities: Customizing of standard protocols to fit specific product development needs.
- Experienced Technical Staff: In-house surgeons and veterinarians, highly trained technicians and the experience that comes from performing thousands of biocompatibility assays.
- On-Site Ancillary Labs: Including histopathology and clinical pathology.
- Operational Excellence: A sustained commitment to continual process improvement to ensure better performance and maximum flexibility.
With our comprehensive menu of integrated services, WuXi AppTec can support your biocompatibility testing through additional programs in materials characterization, custom in-life studies and toxicology.
WuXi AppTec provides chemistry evaluations based on your needs at any stage of your product development. And our experts can help you link your chemistry to your biocompatibility data in a risk assessment evaluation. Click here for more information on materials characterization.
Custom In-Life Studies
As medical devices and combination products frequently require testing beyond the standard ISO/FDA 10993 methodologies, WuXi AppTec’s capabilities include GLP and R&D device/material studies customized to meet specific product evaluation requirements. Click here for more information on in-life studies and other preclinical services.
WuXi AppTec’s toxicology program has been designed to address the unique challenges specific to evaluating the safety of medical devices and combination products. With our many years of experience, we stand apart with a toxicology program that is built on a strong foundation in both medical device biocompatibility and drug safety evaluations. Our toxicology team includes Ph.D. toxicologists and material specialists, as well as highly experienced surgeons and pathologists, with the specific expertise needed to address the special requirements of medical device studies. Click here for more information on toxicology testing for devices and combination products.
For more details on available testing services, click here to access the Catalog of Services for Devices and Combination Products.