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Biocompatibility rationale and justification for an early startup


An early start up medical device company developing innovative devices for the sports industry. Company is specialized in developing compression and cold therapy technology for injury treatment for athletes. Also the device helps the athletes in post-operative recovery.


  • Our experts analyzed the product, reviewed ISO-10993 and FDA G#95 memorandum requirements.
  • Analyzed the device to see whether a rationale can be written instead of testing
  • Identified/analyzed different components of the device and its impact on the device
  • Conducted thorough literature search of predicate devices to substantiate our position of not conducting the tests
  • Conducted the risk analysis of device material
  • Reviewed prior test results on the device and prepared summary report
  • Performed minimal tests in GLP environment
  • Analyzed results and included cytotoxicity data in the risk assessment
  • Wrote white paper/rationales for many tests that are not required
  • Prepared detailed summary package to support FDA 510 K application


Produced a Biocompatibility risk assessment (rationale) report and prepared a detailed summary device package to support FDA 510 K application
This activity resulted in a saving of ~50% of the original cost quoted by the leading test labs and 4 months of time. The client was really excited with the outcome.