Thought Leadership



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Author: Dan Sterling | April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
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Author: Keith Handler | July 23, 2019

Why Cybersecurity is Becoming More Important in the Medical Device Industry

Cybersecurity in the medical device world has evolved from a footnote to a front-page headline. Articles with titles like “Medical Devices are the Next Security Nightmare” (Wired) and “Medical...
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circuit board graphic

Author: Keith Handler | July 16, 2019

A New Era of Cybersecurity

Cybersecurity has become a major concern over the years as technology has advanced. Device manufacturers are searching for ways to keep security up to date with the demand for stricter scrutiny for...
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security graphic

Author: Keith Handler | February 7, 2019

US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

What Does it Mean for the Medical Device Industry? The current ever-changing landscape of cybersecurity threats and hazards, amongst ransomware campaigns and remote vulnerability cracks, call for...
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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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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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Resources

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September 10, 2021

Types of Medical Device Patents: What You Need to Know

In recent years, we’ve seen more innovation in medical devices, particularly with the proliferation of mobile medical devices—a trend that exploded further due to the COVID pandemic. With...
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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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