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.


Author: Dan Sterling | October 24, 2018

Software FMEA

The Effective Software FMEA Risk Management Approach Software FMEA, (Software Failure Modes and Effects Analysis) is a method of risk management that identifies single-fault failure modes in...
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CAPA issue resolution assistance

Author: Dan Sterling | October 7, 2018

ISO 14971

Considered the internationally accepted standard for the medical device industry, ISO 14971 is a guide for risk management of medical device manufacturing....
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Device Engineering

Author: Dan Sterling | April 2, 2018

FDA 483

Understanding Form FDA 483 Observations The FDA conducts inspections on Class II and Class III medical device companies either for pre-approval before products are cleared for release, impromptu...
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person using a computer

Author: Dan Sterling | February 24, 2018

Gap Analysis

Bridging the Gap between Good to Even Greater All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such as the FDA Quality...
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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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Resources

A medical professional works on a mobile app for medical devices

August 10, 2021

The Proliferation of Mobile Medical Devices—Revolutionizing Healthcare

Mobile devices are ubiquitous in today’s day and age; they’re everywhere—and for good reason: your smartphone is a hand-held computer allowing you to stay connected at all times. As a result,...
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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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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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