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Wherever you are in your product development lifecycle,
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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

Engineer on computer reviewing software design for medical device.

October 11, 2023

Mastering the Dynamics of Software Design for Medical Devices

Navigating the complex world of regulatory affairs for medical device software design can feel like trying to find your way out of a complex spider web. Each strand represents a different...
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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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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