AMRI has extensive experience performing Complaint Handling for various commercial medical device products; we will gladly work with your company to learn about your specific devices in order to develop comprehensive Complaint Handling programs. Using an outside, independent testing laboratory to provide Complaint Handling services can free up precious resources for companies to concentrate on product development.
Complaint Handling programs generally include development of a step-by-step protocol which we will use to routinely and consistently document device inspection and complaint analysis. Protocols can include multiple evaluation procedures, including but not limited to visual inspection, volume determination, microscopy and photography, recovery processes, full disassembly of the device, and particulate identification.
Patients can send the medical devices with which they have complaints directly to our testing laboratory, and we will review all documentation and perform Complaint Handling analysis per the customized protocol in order to determine whether the device failure was due to device malfunction, manufacturing defect, or simply due to user error. AMRI will be sure to comply with any of your company’s internal complaint timeline requirements.