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Medical Device Biocompatibility Testing

Medical devices cannot be introduced to the market without comprehensive testing.  Biocompatibility testing determines if your product is safe for contact with, or implantation into, the body, as necessary for regulatory approval.

We perform:

  • Extractables and Leachables method development and testing
  • Chemical, physical, morphological and topographical characterization of materials
  • Identification and quantification of degradation products (polymers, metals, ceramics) including sample preparation
  • Ethylene Oxide sterilization - residuals testing
  • Cytotoxicity testing
  • Benchmark analysis of your product vs. a predicate – important to avoid doing unnecessary in vivo trials

We analyse and interpret the in-depth data that we produce to offer you a full support service in all of your testing with us.  We test to ISO 10993 (parts 5, 7, 9, 12, 13, 14, 15, 18 and 19) – an essential requirement for regulatory submission.

Should failure occur which is caused by biocompatibility issues, we can help to solve those failures quickly and effectively.

In vivo animal testing is not offered in our portfolio of biocompatibility services.

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