Sterling Medical Devices performed development on a Class II orthopedic imaging system with Moderate Level of Concern software. Our client had acquired an unfinished software application, which we worked to complete. Particular focus was given to simplifying features and removing unnecessary requirements. We also updated the application to be compatible with Windows 7, resolved remaining bugs from the software, and completed the design history file.
Sterling provided software lifecycle development services and delivered the DHF to be used as part of a regulatory submission. The application was completed in several phases: planning and requirements documentation, software design updates and implementation, authoring of the verification protocol, and formal verification testing. Development was performed under Sterling’s QMS then transferred to the client’s QMS.