Medical Device Design Industry Blog



Explore our Sterling PLM blog for the latest insights, best practices, tips and tricks to help you manage all facets of the product development lifecycle. Our product development blog shares ways to improve traceability, increase collaboration and ensure compliance throughout your project.


design-medical-device-sharp

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
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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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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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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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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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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

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

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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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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Resources

design-medical-device-sharp

September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
Read More >

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...
Read More >
Potential Coronavirus Treatment

April 29, 2020

Sterling Medical Devices Partners with Cedars-Sinai and Aytu BioScience on Potential Coronavirus Treatment

MOONACHIE, NJ, April 29, 2020 — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, announced today their partnership with...
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