We at Biocomptesting.com put clients’ interests first and always give advice which is in the best interest of clients. Yes, it’s really possible to save biocompatibility testing cost up to 50% and successfully get FDA or CE marking approval for your device.
Here is how?
By writing Biocompatibility Risk Assessment Reports; rationale/ justification reports based on the Substantial Equivalency (SE) of the device and by conducting a thorough literature search. As part of the exercise, we thoroughly review and analyze the data on predicate devices, material components, existing biocompatibility data, etc.
Before you explore the possibility of full blown biocompatibility tests for your device, please give us call to find whether we can save up to 50% of the test costs and also get quick approval for your device. Generally, we can save up to 6 weeks of time by going this route. We have successfully completed many projects in this area and are completely aware of all the pitfalls.