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Sterling Medical Devices participated in the development of a Class I intraoral dental imaging system. The system uses an HD camera to provide real-time picture and video for diagnosis and patient communication. The system is supported by a PC and associated software. We authored a complete Design History File (DHF) for the system. We first completed planning and requirements documentation, including hazard analysis and mitigation. The DHF also included a software architecture document, software detailed design description, and overall hardware design document. We developed verification test protocols for the software and hardware and completed dry run, ad hoc, and formal testing of the device which was approved upon FDA submission. Development was performed under the client’s QMS.
February 18, 2021
November 23, 2020