Medical Device Design Industry Blog



The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.


Nick Testing Web

Author: Dan Sterling | February 7, 2018

Hazard Analysis

Role of Hazard Analysis in ISO 14971 Medical device hazard analysis is a fundamental requirement of ISO 14971 risk management. Hazard analysis entails identification of hazards from possible...
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Author: Dan Sterling | October 8, 2015

Developing Medical Device Software

"Developing Medical Device Software," New Med Device Online Article Series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device...
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Author: Dan Sterling | September 23, 2015

When Medical Device Software Fails Due to Improper Verification and Validation

Software can be an essential component of your medical device, whether you’re designing a new product or improving the functionality of an existing one. Medical device software continues to change...
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Author: Dan Sterling | July 29, 2015

White Paper – 4 Factors to Consider When Developing Your mHealth Product

4 Factors to Consider When Developing Your mHealth Product Successful FDA submission of your mHealth product not only hinges on the accuracy of your data and reliability of your software, but on...
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Author: Keith Handler | July 28, 2015

Is Your Medical Device an Entry Point for a Cyber Attack?

The Internet of Things (Iot), the continual proliferation of mobile medical devices, and the growing amount of data in hospital systems are trends medical device manufacturers should closely follow....
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Author: Dan Sterling | July 7, 2015

Should the FDA’s Regulatory Oversight of Medical Device Apps be Limited Any Further?

The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly...
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The 21st Century Cures Act - Medical Device Industry

Author: Dan Sterling | June 9, 2015

The 21st Century Cures Act: The Current Talk of the Medical Device Industry

A better approach than limiting the FDAs scope along certain criteria through legislation would be to allow the FDA to be more nimble and empowered, with oversight to prevent regulatory abuse. The...
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Author: Dan Sterling | February 3, 2015

What is ISO 14971?

ISO 14971 is the application of a risk management process for medical devices. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk...
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Author: Dan Sterling | January 27, 2015

Guidelines to Follow When Creating Mobile Medical Device Apps

Many new software applications are being developed for use on mobile platforms (smart phones, tablets, etc.). Before delving into the steps to be taken to develop such an application, we should first...
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Resources

Sterling Medical Devices's Dan Sterling speaking

December 17, 2020

Here in New Jersey, Sterling Medical Devices Makes Med Tech to Order

Dan Sterling of Sterling Medical Devices | Screenshot by Esther Surden Suppose you are developing an implant that involves both hardware and software, or an external device for diagnosing a...
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healight

November 5, 2020

Healight: The Moonshot Not Yet Heard Round the World

Imagine a technology so innovative and groundbreaking in its potential impact that its sponsor is calling it “a moonshot” and “an opportunity so big you could build an entire company around...
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Person working on medical device

October 29, 2020

Sterling Medical Devices Unveils Innovation Growth

MOONACHIE, NJ — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, is pleased to announce the renovation of their Regulatory Affairs Department that will now focus on providing strategic guidance and collaboration...
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