Medical Devices & Biocompatibility

The selection and evaluation of materials and devices intended for use in humans requires a structured program of assessment to establish efficacy, biocompatibility, and safety.  It is recommended that all safety and definitive efficacy testing comply with Good Laboratory Practice (GLP) regulations.  Sinclair Research has experience conducting custom device studies in animal models.  We offer large animal species including swine and sheep, extensive surgical capabilities, and the ability to conduct custom GLP studies for safety and efficacy models.

We utilize our many years of experience in laboratory animal surgical models to provide exceptional expertise to assist medical device manufacturers in designing thorough, well-constructed efficacy testing programs that satisfy regulatory requirements.  We can host visiting surgeons and provide surgical assistance and/or we can train with visiting experts to allow us to take over surgical procedures as appropriate.  We can provide acute, subchronic, and, if needed, chronic toxicity studies in a variety of species that includes swine and small ruminants.  In vitro device services are provided by a partner laboratory, including cytotoxicity, genotoxicity, and endotoxin testing.

Based on the wide variety of products that are considered medical devices, no two development programs are exactly alike.  Sinclair is ready to support the unique needs of your program by providing you access to a large AAALAC Accredited animal facility capable of housing a variety of animal species for short and long term studies.  Our flexibility and surgical capabilities coupled with our experience with efficacy and toxicology models makes us a valuable partner for medical device evaluations.

 

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