Medical Device Testing

Verification

It is imperative to know how to properly test your medical device. If you test your device too frequently and inefficiently this could lead you to blowing your budget, but if you wait too long in your device’s life-cycle or do not test the proper things, this could lead you to redesign your device.

Validation

When the time comes to validate the your medical device software, no matter how far along you are in the development process, it is necessary to rely on an experienced partner that can independently guide you throughout the medical device software validation process. 

Resources

fda real world evidence on mobile device

July 28, 2021

FDA’s Real-World Evidence Program – Summary of Patient Data Assessment Report

The FDA is responsible for ensuring the safety and effectiveness of regulated medical devices and assuring that patients have timely access to the devices while advancing innovation. It is a...
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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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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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