Medical Device Qualification
Exponent staff have designed and developed the signal recognition and classification algorithms (modules) for the software that controlled a nucleic acid diagnostics device. We were involved in the risk assessment activities of the system (FMEA), requirements specification, design description, coding, module, integration, and system testing of the entire code. This included producing the complaining documents for the modules coded by our staff and others as required. These documents included Software Requirements Specification (SRS), Software Design Description (SDD), Module Test Protocol and Report, Integration Test Protocol, and Report. The device was FDA approved under a 510K submission.