Optical Surgery System

Sterling Medical Devices assisted in the documentation and test of a hardware and software system used in optical surgery. The Major Level of Concern system contained five processors. The master processor controls the user interface and main system logic while … Continued

Image Processing Connections System

Sterling Medical Devices assisted in the iterative development of a Major Level of Concern connection system between a series of video processors and a third party computer system. The system was written in C#. Sterling provided documentation, development, and test … Continued

Remote Support WebApp for Handheld Tinnitus System

Sterling Medical Devices assisted in the iterative development of support software for a Class II device that addresses the underlying cause of tinnitus. Sterling’s primary development activity was redeveloping the Moderate level of concern software, originally written in Flex. The … Continued

Defibrillator IDE

Sterling Medical Devices aided in the creation of an Integrated Development Environment (IDE) for the generation of defibrillator software and firmware development. First, Sterling developed a State Machine Analysis command line tool to be integrated into the IDE. Sterling also … Continued

First Generation Strip Reader Hardware

Sterling assisted in the development of the hardware and electronics for a strip reader that performs dry chemistry urine analysis. Sterling re-engineered the main prototype board for commercial release readiness and large-scale manufacturability. Sterling developed the system with room for … Continued

Microburst R&D Software Project

Sterling Medical Devices assisted in the development of a next-generation Class III microburst stimulation system. The system includes Major level of concern software as well as a handheld device powered by a TI MSP430 microcontroller. The client came to Sterling … Continued

Genetic Analyzer

Sterling Medical Devices wrote documentation and performed software development for a prognostic genetic analyzer.

Dental imaging systems

Sterling Medical Devices participated in the development of a Class I intraoral dental imaging system. The system uses an HD camera to provide real-time picture and video for diagnosis and patient communication. The system is supported by a PC and … Continued

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 … Continued

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 … Continued

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 … Continued

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, … Continued

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, … Continued

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 … Continued

Glucose Monitors

Sterling Medical Devices assisted in developing a Class II Glucose Meter with Moderate Level of Concern software. The handheld device combines a strip reader, touch-screen LCD, SD card reader, SIM card reader, gyroscope, wireless capabilities including 3G and Wi-Fi, and … Continued

Orthopedic Planning and Correction System

Sterling Medical Devices developed a fully-updated web-based application for a Class II orthopedic planning and correction system with Moderate Level of Concern software. The software recommends to surgeons a day-by-day treatment plan for fixing long bone fractures based on patient … Continued

Cardiopulmonary Resuscitator System

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. Our team added a feedback mechanism to the device to address the FDA’s response to … Continued

Blood Analyzer Software

Sterling Medical Devices participated in the development of a Class II blood analyzer system with Moderate Level-of-Concern software. The diagnostic system is composed of an embedded device coupled with programmer/user interface units and included problem domain technologies. In order to … Continued

Artificial Hearts

Sterling Medical Devices participated in the development of a Class III hospital driver to support patients who’ve received an implanted heart until their condition becomes clinically stable.

Heart sound analysis system

This device was developed to collect acoustic data of the heart function and analyze the data to generate readings including heart rate.

Heart monitor system

This project focused on the development, testing, and refinement of the software and hardware for a heart monitor system.

Gynecological scope system

The system was developed to collect images using a custom camera system which are stored for use by the physician together with notes.

Glucose strip meter system

Sterling developed a glucose strip meter system that reads strips, calculates glucose readings, displays current values, and charts the data.

Glucose monitor system

A medical device company had a need for a glucose monitor system that connects to a non-invasive sensor to regularly upload glucose readings.

Active Drug Delivery System

Sterling developed this drug delivery system with different wearable instruments providing drug delivery; a complete mechanical solution and an electromechanical solution.

Infusion Pump System

Infusion Pump System

This medical device company had a need for a software driven and microprocessor controlled electromechanical infusion pump system.

Gene Assay System

Gene Assay System

A gene assay system was developed to post process Gene expression assay system data to identify specific markers of potential diseases.

ECG Holter Monitor System

ECG Holter Monitor System

This project focused on the development, testing, and refinement of the hardware and software for an ECG Holter monitor system.

Drug Injector System

Drug Injector System

This medical device company had a need for drug injector device which includes a mechanical and electrical drug delivery system.

DICOM Image Display System

DICOM Image Display System

A medical device company had a need for a DICOM image display system to allow physician diagnosis based on captured images.

DICOM Image Capture System

DICOM Image Capture System

A DICOM image capture system was developed to capture DICOM images of patient skeletal features; the system connects to a PACS server.

DICOM Image Analysis System

DICOM Image Analysis System

An orthopedic medical device company had a need for a DICOM image analysis system for a custom orthopedic product.

Design History Remediation

Design History Remediation

An early stage medical device company had a need for Design History Remediation for a controller which was developed outside of design controls.

Continua Based System

Continua Based System

Sterling developed interfaces for a client’s healthcare products based on Continua, a system of interoperable, personal connected health solutions.

Blood test systems – Microcard-based

Cell Counting System

This project focused on the development, testing, and refinement of image segmentation software for a cell counting system.

Catheter System

Catheter System

A medical device company purchased catheter products from another company and needed DHF documents reviewed/updated to meet quality system requirements.

Cardiopulmonary Resuscitator System

Cardiopulmonary Resuscitator System

A medical device company had a need for cardiopulmonary resuscitator system which helps untrained civilians to administer CPR to critical patients.

CAN Protocols

CAN Protocols

This project focused on the development of CAN protocols – the system consist of a Class III medical device and ancillary devices.

Blood Test Systems – Platelets

Blood Test Systems – Platelets

A medical device company had a need for a blood test system that analyzes platelets and measures a patient’s platelet function.

Blood Sample Diagnostic Analyzer

Blood Sample Diagnostic Analyzer

Sterling developed a blood sample diagnostic analyzer which is used with a disposable biochip to determine chemical/biological analytes in fluid samples.

Biosensor measurement system

Biosensor Measurement System

This biosensor measurement system, which includes a non-invasive sensor and smartphone app, continuously measures patient health data.

Assay Instrument

Assay Instrument

The company had a need for an assay instrument which provides results from a fluorescence microplate reader system.

Android Based Medical App

This Android-based medical device app was created for care givers/patients to configure treatment and observe treatment effectiveness.

Ablation Controller

Ablation Therapy System

This medical device company turned to Sterling Medical Devices to develop an ablation system which consists of a Radio Frequency Generator.