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 evaluation, risk mitigations, and a residual risk analysis. This standard helps guide the process for medical device manufacturers to ensure that the product is…

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 consider what it takes to consider the application a medical device. According to the FDA Guidance, Mobile Medical Device Applications (Apps) have special FDA considerations…

5 Mistakes Medical Device Startup Companies Need to Avoid

The path through the FDA approval process to market may seem perilous, but avoid these five common mistakes, follow advice from Sterling’s Bruce Swope and Erik Hilliard, and your medical device startup can bring that once-in-a-lifetime medical device idea to market.   #1 – Medical device startups want the first thing they roll out to…

Sterling Medical Devices Holiday Party 2013

Great Party!!! Thank you all for coming. Had a great attendance of over 50 Sterling employees and spouses.  Thank you all for making it possible.

Guidelines to Follow When Creating A Medical Device Mobile Application

Guide Lines to Follow Many new medical mobile applications are being developed for use on mobile platforms (smart phones, tablets, etc.). Before delving into the steps to be taken to develop a medical device mobile application, we should first consider what it takes to consider the application a medical device. According to the FDA Guidance, Mobile…

Sterling Medical Devices Expands Operations With New Hardware Design Center Increasing Medical Device Development Capabilites

Sterling Medical Devices, a leader in product design, development and testing for the medical device industry, dramatically expanded its workspace with the opening of a new hardware design center that supports the company’s growing hardware development staff. The new building adds more than 4,600 square feet of office and laboratory space to Sterling’s existing operations…

Sterling Medical Devices Achieves Sterling Software Quality With Coverity

Written by Chris Adlard, Courtesy of Coverity Here follows a short blog about Medical Devices and Systems Leader, Sterling Medical Devices, and their development testing successes, led by Vice President of Engineering, Bruce Swope. Sterling. A word that can either mean a type of high-quality, fortified silver used in table utensils and jewelry, or that…

Things You Should Know About Medical Device Development

Thought Leadership: Getting your medical device through the FDA approval process Designing, developing and bringing to market a new medical device is a complex process. Here are some of the things you need to know about the medical device FDA approval process: FDA and CE Regulations: Medical devices are covered by FDA regulations in the…

Sterling Adds Steve Hartman to Management Team

Bringing Over 15 Years of Medical Device Development Experience To Further Enhance the Client Experience ROCHELLE PARK, N.J. — Sterling Medical Devices, specializing in the development and testing of state-of-the-art medical devices, announces that Steve Hartman has joined the company as Program Manager. Mr. Hartman brings with him over fifteen years of medical device experience…

Sterling Enhances Brand with Name Change to Sterling Medical Devices

With the launch of its new web site and recognizing a shift in customer demands, SterlingTech, Inc. changes its name to Sterling Medical Devices. Driven by its expertise in providing software and electronics development exclusively to the medical device industry, SterlingTech briefly took on the name Sterling Smartware Solutions; however, customers quickly drove the company…

Sterling Expands Medical Device Development Capabilities, Hires Larry Bischoff

SterlingTech Software Expands Medical Device Development Capabilities, Hires Larry Bischoff as Embedded Systems Manager New hire bolsters firm’s hardware and software development solutions Rochelle Park, NJ—SterlingTech Software, a leader in custom solutions for the medical device industry, announced today that it has hired Larry Bischoff as Embedded Systems Manager. Mr. Bischoff will oversee SterlingTech’s Development…

Sterling Receives ISO 13485 Certification For Medical Devices

SterlingTech Software, a leader in custom software solutions for the medical device industry, announced today that it has received ISO 13485 Certification. ISO 13485 is an internationally recognized quality standard for the design, development, production, and sale of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services…