Orthopedic Imaging System

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…

Breathing Pacemakers

Sterling Medical Devices participated in the development of a Class III breathing pacemaker intended for use by patients who have lost neurological control of respiration. The pacemaker is now used in over 20 countries. Sterling’s primary task was developing the Major Level of Concern software. The software functionality duplicated the functionality of the existing analog…

Preoperatives Planning Tools

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…

Plasma Pump Software

Sterling Medical Devices assisted in development of a Class III pump intended for use in apheresis, a process that requires filtering blood into plasma and cells. The pump pushes blood through a plasma separator. The major level of concern software, written in C, runs on a digital signal processor. Sterling performed independent code review, unit…

Gynecological Scope

Sterling Medical Devices participated in the development of a proof-of-concept gynecological scope prototype. During phase 1, Sterling authored a project plan and requirements documentation designed to meet our Client’s aggressive timeline. We later designed the GUI, assisted in software development, and authored and executed test protocols. The software system was developed for use on macOS.…

CAPA Issue Resolution Assistance

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…