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Biocompatibility testing and rationale for a startup manufacturer of neonatal medical devices


Startup medical device company specializing in developing products for neonatal patients. Company is involved in developing devices with special emphasis on making significant improvements in blood draw techniques for the neonatal patients. Client wanted to submit for 510 (k) clearances (FDA), Canadian Medical licensing, and CE marking for its product. One of the requirements for these submissions is to demonstrate biocompatibility of the device.


  • 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
  • Performed GLP Cytotoxicity and Hemocompatibility test for the device
  • Analyzed results and included cytotoxicity data in the risk assessment
  • Wrote white paper/rationales for many tests that are not required
  • Prepared biocompatibility summary package to support FDA 510 K application


Produced a Biocompatibility risk assessment (rationale) report and prepared a detailed biocompatibility 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.