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

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…

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…

Glucose Monitors

Sterling Medical Devices assisted in developing a Class II Glucose Meter with Moderate Level of Concern software.

CPR Assistance System

Sterling Medical Devices participated in the development of a Class III device that helps an untrained civilian administer CPR to a patient in critical condition.