Hazard Analysis

Sterling Medical Devices Sponsors Depuy Synthes Golf Outing Fundraiser

On September 19, 2016, Sterling Medical Devices sponsored and participated in Depuy Synthes 3rd Annual fundraiser event.. The proceeds from the golf outing fundraiser at the Honeybrook Golf Club in Pennsylvania went to the United Way of Chester County to benefit the local community. We are happy to support Depuy Synthes, a subsidiary of Johnson…

Sterling Medical Devices sponsored ‘Newark Innovation Acceleration Challenge’ event.

Sterling Medical Devices sponsored ‘Newark Innovation Acceleration Challenge’ event. Dan Sterling, President, said regarding the presentations in the event that he ‘greatly respects the student’s ability to invent a totally new product, adding that his firm is innovative when it comes to engineering processes and services, and “there is a great deal of innovation in…

Sterling receives ‘Business Partner of the Year’ award

Dan Sterling receiving ‘Business Partner of the Year” award Sterling Medical Devices received ‘Business Partner of the Year’ award by The Bergen County Technical Schools in Bergen County, New Jersey. The award was based on Sterling’s significant contributions to the district, including help with the district’s curriculum development through advisory boards, and the institution of…

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 software companies should consider preparing for a potential expansion of this case practice according to Sterling Medical Devices engineering managers, Steve Hartman and Nick Oshman, authors of a…

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 and expand across many types of medical devices. Patient safety must be a primary concern of medical device companies. The FDA continuously monitors and reports…

Sterling Medical Devices Sponsors the Entrepreneurship Boot Camp at AdvaMed 2015

Rochelle Park, NJ – September 17, 2015 – Sterling Medical Devices announces that it is sponsoring the Entrepreneurship Boot Camp at AdvaMed 2015: The MedTech Conference, October 5-7 in San Diego. Bruce Swope, vice president of engineering of Sterling Medical Devices, will deliver the opening remarks and serve as moderator throughout the program.

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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 your development process as well. Modern-day mobile medical technology is breaking molds in the medical device industry, opening up new opportunities for doctors…

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. Similarly, medical device manufacturers should track cybersecurity trends. Just last year the number of medical device cyber attacks on government systems grew to nearly 61,000*. Because…

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 talking about the FDA’s role in regulating the growing wave of new medical device apps in the market. The FDA has provided guidance and regulations for…

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 21st Century Cures Act is the talk of the medical device industry and Congress is moving quickly on it. What can passage of…

Sterling Medical Devices Addresses Business Leaders in Japan

As one of the top medical device leaders in Japan, management from Sterling Medical Devices presented to an exclusive group of Japanese businesses interested in learning more about how to access the medical device market in the United States at private events held in Tokyo and Osaka in June 2014. Speaking at the request of…