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Biocompatibility testing and rationale an innovative company manufacturing devices for emergency room


Company is a global medical device product development that specializes in innovative and cost effective medical supplies. Company was founded over 10 years ago and offer medical device to EMS, dialysis, dental and animal health.


  • 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 for not conducting the tests
  • Conducted the risk analysis of device material
  • Reviewed prior test results on the device and prepared summary report
  • Performed GLP Cytotoxicity test for the device
  • Analyzed results and included cytotoxicity data in the risk assessment
  • Wrote white paper and 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 response 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.