Startup medical device company specializing in TAVR product. Client wanted to submit for FDA – IDE, Canadian Medical licensing, and CE marking for its product. One of the requirements for these submissions is to demonstrate biocompatibility of the device.
The client’s conversation with the leading test labs resulted in many expensive tests and six months to complete testing. And also the labs consultants help was necessary to compile the entire test results to produce the final report incurring additional expenses.
BridgeMed solutions consultant analyzed the product, reviewed ISO-10993 and FDA G#95 memorandum requirements. Based on the analysis figured out the tests recommended by the labs were off-the shelf tests and are not customized to the product. The consultants customized the tests specific to product, wrote white paper/rationales for many tests that are not required.