Safety evaluation studies (in vitro and in vivo) are conducted on a variety of biomaterials, medical devices and related products to identify the presence of toxins or any other potentially harmful effects of the product. Testing ranges from the initial screening of new materials to product release testing, periodic audit testing and non-clinical or pre-market safety evaluations to meet current FDA and international standards.
We perform testing to evaluate biocompatibility appropriate to the intended use of the component material or finished product. These tests challenge various biological models with the test material or a suitable extract. Specific safety programs follow Food and Drug Administration (FDA) guidance and International Organization for Standardization (ISO) 10993 standards.
In addition to the wide range of in vitro and in vivo toxicology services, NAMSA offers Histopathological services.
Primary test categories used to determine biological effect include:
- Cytotoxicity
- Sensitization
- Intracutaneous Irritation
- Acute Systemic Toxicity
- Subchronic Toxicity
- Genotoxicity
- Implantation
- Hemocompatibility
- Chronic Toxicity
- Carcinogenicity
- Reproductive/Developmental
- Biodegradation
Biocompatibility Test Matrix
