Device Testing Services
Sinclair Research Center has supported the medical device industry with customized surgical studies for many years, establishing a reputation for technical expertise, outstanding communication, on-time reporting and high value. We now further support the device industry with a full range of ISO 10993 Part 1 biocompatibility studies with this same high level of service. We now provide Toxicology, PK and Safety Testing in one facility for drugs, medical devices and drug/device combination products.
Representative capabilities include:
Sensitization Testing (Part 10)
- Guinea Pig Maximization
- Guinea Pig Repeated Patch (Buehler)
Irritation (Part 10)
- Intracutaneous Reactivity
- Primary Skin Irritation
- Ophthalmic studies
Systemic Toxicity (Part 11)
- Acute, Subchronic and Chronic Toxicity
- Dermal
- Ocular
- Soft and Hard Tissue
Implantation (Part 6)
- Intramuscular
- Subcutaneous
- Intraperitoneal
- Spinal (and other orthopedic sites)
- Ocular
- Osteoinduction/Osteoconduction
TK/PK (Part 16)
- Rodent
- Large Animal (including NHP)
Genotoxicity* (Part 3)
- Bacterial Mutagenicity
- Mouse Lymphoma
- Chromosomal Aberration
Hemocompatibility (Part 4)
- Thromboresistance Test (multiple species)
- Compliment Activation*
- Coagulation Studies*
- Platelet and Leukocyte Counts*
- Hemolysis*
Cytotoxicity* (Part 5)
- Agarose Overlay
- MEM Elution
- Direct Contact
- Growth Inhibition
- Extract Colony Assay
Risk Assessment (Part 18)
- Expert consulting available
- Clinical Chemistries
- Necropsy Facilities
Supporting Procedures
- Hematology (5 part differential)
- Histology/Pathology
- Animal models Joint/Cartilage Models
- Studies in 15 species including NHP and Miniature Swine
*In-Vitro Testing Services provided by Nelson Laboratories, Inc.
Sinclair Research Center is a GLP Compliant, USDA licensed and AAALAC approved research facility.
Why choose Sinclair for ISO 10993 Biocompatibility Testing? It's all about communication.
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