Sterling Medical Devices planned and managed development of Class II preoperative planning software for orthopedic surgeons. The moderate level of concern software was developed in C, C++, and C#.
The project began by authoring select Design History File (DHF) documentation collaboratively with our Client including a project plan and schedule, a Software Development Plan, and a Software Requirements Specification. Early SW development included design & development of the prototype UI and application architecture. In the next project phase, we developed system functions including image deformity and manipulation control, correction planning control, construct selection using 3D models, and image export control.
On the documentation side, Sterling wrote the DHF and performed complete system verification and validation. In addition to authoring and executing manual test protocols, we wrote test scripts to automatically test a wide range of functional test cases. Finally, we develop the system’s User Manual.
Development was performed under Sterling’s ISO 13485 certified QMS and later transferred to the client’s QMS.