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.