Medical Device Projects

At Sterling Medical Devices, we provide a wide range of medical device services to help take your ideas for medical device projects from concept to market. Below are some of our past medical device projects to illustrate the scope of work we can provide while respecting the privacy and confidentiality of our clients. If you are looking for more in-depth examples of our design and development work, please review our case studies.



Image Processing Connections System

Applications Desktop Application Desktop Device Web Application

Dental Imaging System

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...
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Orthopedic Imaging System

Applications Desktop Application Web Application

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...
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Implanted Defibrillator / Pacer System

Electro-Mechanical Implanted Devices

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...
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Gynecological Scope

Applications Desktop Application Desktop Device Preoperative Planning Tools Web Application

Preoperative 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...
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doctor reviewing cat scan

Cart-Based/Table Top

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...
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Gynecological room test gynecologist equipment tool ultrasound device unit apparatus examination experience photo picture

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...
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CAPA issue resolution assistance

Software

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)...
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Glucose Monitor

Firmware Handheld/Wearable

Cellular Glucose Monitor

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...
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Orthopedic Planning System

Applications Web Application

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...
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Resources

September 1, 2021

How Long Does it Take the FDA to Approve a Medical Device?

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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