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Sterling Medical Devices participated in the investigation and remediation of five medical devices with CAPA issues, all made by the same company. In general, CAPA (Corrective and Preventive Action) identifies and remediates sources of existing and potential problems. The devices our Client asked us to remediate were software based, written in a combination of C and assembly language. We performed code reviews, unit testing, and full system testing with a focus on error code reporting. We also updated internal product documentation in order to show that CAPA had been taken.
February 18, 2021
September 8, 2020