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Biocompatibility rationale and justification for a global medical device manufacturer


Company is an Ireland division of publicly listed medical device company. The client wanted to write a rationale for biocompatibility for their transcatheter delivery system based on their previous generation of the same device


  • Our experts analyzed the product, reviewed ISO-10993 and FDA G#95 memorandum requirements.
  • Devised rational and testing strategy for Class III device based on substantially equivalent (SE) device
  • Identified and analyzed different components of the device and its impact
  • Conducted thorough literature search of predicate devices
  • Reviewed prior test results on the device and prepared a summary report
  • Analyzed results and include cytotoxicity data in the risk assessment
  • Wrote white paper/rationales for many tests that are not required


This saved ~$150,000 and 4-6 months of time for the company. In addition the company was able to perform First in Human (FIH) trial 6 months earlier than anticipated.