Chemical Characterization is one of the aspects of safety evaluation of medical devices. Depending on the circumstances it can be a great savior in getting device to market or a long potentially painful process.
While understanding the chemical makeup of the device is an important step in that safety evaluation. It is important to also understand the limitations of what it can tell you. It is important to understand the role of chemical characterization in device approval and how to use the information as part of an overall strategy.
This presentation will provide a general overview of the procedures for conducting a chemical characterization, expected outcomes and how that information can be used to support product success, including strategies for when thing may not go as hoped.