Medical Device Testing

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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...

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.

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....

Medical Device Testing

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Resources

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

5 Mistakes Medical Device Startups Make

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

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