The biocompatibility evaluation report is the culmination of all this planning, testing and review. It should start out with a general description or drawing of the medical device. The planned Instructions for Use (IFU) adds a substantial understanding of the device and labeling. Then there should be a complete Bill of materials with each material’s contact type, chemical composition and available data. Addtionally, the source along with catalog numbers demonstrate the stability of the source of the material and helps in the re-evaluation of the Risk assessment when a material does change.
How the product is manufactured, including areas of possible contamination. This requires an intimate knowledge of the manufacturing process. This cannot be done by an outside observer. What is on the premises that could get into or on the device.
A review of all available toxicological data for each component can start the tone of the overall biological evaluation plan.
The biological evaluation plan as it was completed earlier, prior to testing
Reports of biological tests, so that they can be read for confirmation of the conclusion.
A review of the data should include key attributes from every study to demonstrate the validity of the tests and the validity of the conclusion.
Finally a conclusion should be drawn hopefully that the product should pose little to no biocompatibility risk. Nobody wants to hear that their product poses an unacceptable risk to biocompatibility. And if the conclusion is more testing is needed then you are not done yet.