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Biocompatibility Testing including FDA and ISO 10993 standards

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 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.


New Online Sample Extraction Guide!
The online version of NAMSA's Sample Extraction Guide is used to determine the amount of material typically required for the selected test. Click here to try it now.


Visit our new state-of-the-art toxicology laboratory without leaving your office. NAMSA recently opened 2 new facilities; the first in Lyon, France, (Biomatech) and the other at the Northwood, Ohio campus. Click here to take a photo tour.


 


Primary test categories used to determine biological effect include:
  • Cytotoxicity
  • Sensitization
  • Irritation/Intracutaneous
  • Acute Systemic Toxicity
  • Subchronic toxicity
  • Genotoxicity
  • Implantation
  • Hemocompatibility
  • Chronic Toxicity
  • Carcinogenicity
  • Reproductive/Developmental
  • Biodegradation

Biocompatibility Test Matrix

 

Certificate of Compliance
Namsa now offers a Certificate of Compliance for testing programs. Click here to learn more about this convenient regulatory submission document.