Medical Device Testing
In vitro & in vivo biological compatibility/safety evaluations are conducted on biomaterials, medical devices, and related products to identify potential risks for the use of a device in humans. Biocompatibility testing ranges from the screening of new materials to product release testing, audit testing, and pre-market safety evaluations to meet current FDA guidance and ISO 10993 standards.
Testing Parameters include exposure durations options, such as, Limited, Prolonged and Permanent. Many contact options are also available: Skin, Mucous Membrane, Breached or Compromised Surfaces, Blood Path (Indirect), Tissue, Bone, Dentin, and Circulating Blood. Extraction options are configurable to meet your specific ISO requirements.