Manufacturers are required to conduct adequate safety testing of finished devices through preclinical and clinical phases as part of the regulatory clearance process. These guidelines provide a general testing framework to aid manufacturers in the assessment of device biocompatibility. 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.
Sinclair Research has supported the medical device industry with customized surgical studies for many years, establishing a reputation for technical expertise, outstanding communication, prompt reporting, and superior value. Sinclair has experience in all areas of the growing, highly-competitive medical device testing business, and offers a comprehensive selection of ISO protocols. We now provide toxicology, pharmacokinetics, and safety testing in one facility for drugs, medical devices and drug/device combination products. Custom study designs are sometimes required for specialized devices; expert device consultants can be involved in design of custom studies.
Why Biocompatibility Testing for Medical Devices?
Medical devices are required by federal regulation to be tested for safety and efficacy. Medical devices and their component materials may leach chemicals or have surface characteristics that produce undesirable effects when used in or on humans. Surrogate animals are used to detect and assess these potential adverse events prior to human use in clinical trials. The device manufacturer must select and justify the specific tests most appropriate for the establishment of product safety and compliance with regulatory agency requirements.