Medical Devices & Biocompatibility

The selection and evaluation of materials and devices intended for use in humans requires a structured program of assessment to establish biocompatibility and safety, and it is recommended that all testing comply with Good Laboratory Practice (GLP) regulations. Sinclair Research has extensive experience conducting classical and custom device studies in animal models. We offer U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO), Japanese Ministry of Health, Labor and Welfare (JMHLW), and United States Pharmacopeia (USP) testing, including ISO 10993 thromboresistance and osteoconduction/osteoresistance studies, as well as a full range of ISO 10993 Part I biocompatibility studies. We recognize that American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI), or Association for the Advancement of Medical Instrumentation (AAMI) standards also apply for some devices, and we are able to custom-design each study accordingly.  Additional details of protocol designs are available upon request; expert device consultants can be involved in design of custom studies.

We utilize our many years of experience in biocompatibility testing to also provide exceptional expertise to assist medical device manufacturers in designing thorough, well-constructed testing programs that satisfy regulatory requirements. Testing categories for an initial biological effect consist of cytotoxicity, intradermal and topical sensitization, dermal and ocular irritation, systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, implantation, and hemo-compatibility. Other less frequently required tests include chronic toxicity and carcinogenicity. In vitro device services are provided by a partner laboratory, including cytotoxicity, genotoxicity, and endotoxin testing.

Our Medical Devices Service is an A2LA-accredited (certification #3221.01), and ISO 17025-compliant laboratory for biological testing; they are able to perform the following tests:

  • Thromboresistence Test – Canine, Porcine, Ovine
  • Intramuscular and Subcutaneous Implant Tests – 7 days to 52 weeks – Rabbit
  • Osteoinduction Testing – Athymic Mouse, Rat
  • Acute Systemic Toxicology Test – Mouse, Rat
  • Subchronic Toxicology Test – 14 days – Mouse, Rat
  • Subchronic Toxicology Test – 28 days – Mouse, Rat
  • Chronic Toxicology Testing – Mouse, Rat
  • Primary Skin Irritation Tests – Rabbit
  • Intracutaneous Irritation Tests – Rabbit
  • Maximization Sensitization Test – Guinea Pig
  • Buehler Repeat Patch Sensitization Tests – Guinea Pig
  • Ocular Irritation Testing – Rabbit
  • Micronucleus Genotoxicity Test – Mouse, Rat
  • Material Mediated Pyrogen Test – Rabbit

Helpful Information

Biocompatibility Test Services

Test Article Usage Chart

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