Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an increased risk to patient safety and product efficacy. Software architects face difficult decisions regarding product development and patient safety. Medical Devices: Five Principles to Keep Up with…

Laparoscopic Imaging System Verification

Sterling aided in the verification to an update of an imaging system. This system is Class II device with a Moderate Level of Concern. The verification protocols covers the desktop application, CCU Firmware, FPGA Firmware, communication between external PulmoView and Desktop software, Video Image Quality, CCU Hardware, and  Main Board Hardware. The verification protocol include…

Image-Guided Surgery System

Sterling Medical Devices participated in the development of an image-guided surgery system including optical tracking devices and localization probes. The system helps surgeons obtain an accurate image of the operative field (an organ). Its electromechanical components include a wand with infrared diodes plugged into a PC, IR tracking of the wand, a PC for signal…

Remote Support Web Application Software

Sterling Medical Devices helped redevelop a remote support web application software targeted to address the underlying cause of tinnitus. The original system was written in Flex. The system has a handheld acoustic stimuli generator, earphones, and pleasant treatment sounds. There are three sounds included, but the system is also customizable to the patient. The software…

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…