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…

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…

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 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…