Low cost Biocompatibility testing - medical devices

LMG can help medical device / drug companies to conduct Bio-compatibility tests at overseas lab at attractive rates which follow international protocols, acceptable to FDA and CE Marking.
We can assist you to conduct the following tests

  • ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
  • ISO 10993-4:2002/Amd 1:2006 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
  • ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-6:2007 Biological evaluation of medical devices Part 6: Tests for local effects after implantation.
  • ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.
  • ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products.
  • ISO 10993-10:2002/Amd 1:2006 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity.
  • ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-13:1998 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices.
  • ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics.
  • ISO 10993-15:2000 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys.
  • ISO 10993-16:1997 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables.
  • ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances.
  • ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials.
  • ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials.