Biocompatibility and Devices

CBI offers comprehensive biocompatibility testing — in compliance with ISO-10993, ISO-9394 and US Pharmacopeial Convention and Code of Federal Regulations standards — in a rapid and cost-effective manner.

In Vivo Assays

  • Acute, systemic, subacute, chronic and carcinogenicity toxicity studies
  • Beuhler, Draize and Magnussen-Kligman maximization testing
  • Biocompatibility
  • Bone, joint,  and orthopedic
  • Contact lens testing, ISO-9394
  • Device-drug combinations
  • Device-stem cell combinations
  • Dermal, ocular, mucosal irritation testing
  • Long-term surgical implantation studies
  • Muscle, bone, subcutaneous and intradermal implantation
  • Topical, intracutaneous, ocular and primary skin irritation testing

CBI has conducted numerous studies related to dural, amnionic, pericardial and other patches, coated films, sutures, matrices, osteoinduction materials, cartilage regeneration, morselized bone, spinal fusion, bone regeneration and tendon repair.

In Vitro Assays

  • Blood compatibility testing (hemocompatibility)
  • Cytotoxicity testing (Agar overlay and MEM elution)
  • Other in vitro assays