Gap Assessment

Your device has undergone a design change, manufacturing process change, location change, material change, intended use change, or specific requests by regulatory bodies! Our experts can help you in performing a Gap assessment based on

• how a test article compares to the proposed medical device in its final finished form in formulation, processing, sterilization, and geometry;
• the interpretation of existing data and results of testing;
• the need for any additional data to complete the biological evaluation;
• the rationale for selection and/or waiving of tests
• overall biological safety conclusions for the medical device.