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CPR System

Development

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....
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Glucose strip meter system Glucose strip meter system

Development Hardware Software Testing

Glucose Strip Meter System

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

Catheter System

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

Development Software

CAN Protocols

This project focused on the development of CAN protocols – the system consist of a Class III medical device and ancillary devices....
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Blood Test Systems – Microcard-Based

Development

Blood Test Systems

A point-of-care diagnostic system company had a need for microcard-based blood test systems that enabled operators to make diagnostic decisions....
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Resources

Medical professional pointing at FDA icon.

November 3, 2023

An Overview of the FDA’s Application of Human Factors Engineering Principles for Combination Products Guidance

In September 2023, the FDA Office of Combination Products (OCP) released the Application of Human Factors Engineering Principles for Combination Products, a finalized version of the February...
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5 Mistakes Medical Device Startups Make

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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