The use of a medical device as interventional therapy or as a delivery tool in conjunction with a therapeutic compound is quickly changing the preclinical development process for both devices and drugs. Charles River has the expertise to provide unique solutions to companies developing products in a variety of therapeutic areas. We offer a range of safety evaluation and biocompatibility services for medical devices, including studies designed in accordance with ISO 10993 and USP <88> guidelines.
Testing requirements are generally based on the type of device and the duration of patient contact. The number and type of specific safety tests required to assess product safety and compliance are dependent on the individual characteristics of the device, its component materials, and its intended clinical use. With experience in testing many different types of medical devices, we work with you to ensure that the most appropriate program is designed for your product. We can also advise on any potential technical challenges, including preparation of eluates suitable for testing and considerations relating to implantation techniques.
Our testing services include:
• Skin irritation studies
• Biocompatibility testing
• Sensitization studies
• Genetic toxicology
• Haemolysis studies
• Cytotoxicity studies
• Acute, subchronic and chronic toxicology (rodent and nonrodent species)
• Systemic toxiocology
• Implantation studies
• Biodegradation studies
• Reproductive and carcinogenicity studies
Additional medical device services include:
• Specialized bone evaluations
• Ocular implant toxicity testing
• Medical device pathology
• Specialized bone implant pathology