The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

Over the next year, the term human factors must become very important to those who develop and market medical devices (if the term is not already). Developers must take a look at some common ...

The FDA also issued guidance regarding clinical trials and medical devices that describes the agency's process for approving applications from companies that want to conduct clinical trials involving ...

Some medical technologies are just plain cool. But tech that’s only cool is never enough. It must solve specific health problems, improve each patient’s quality of care, and be easy to use. To create ...

Engineers could avoid expensive redesigns by planning medical device testing early in development with expert guidance.

Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time ...

(RTTNews) - 908 Devices (MASS) announced that GlaxoSmithKline (GSK) has purchased an additional REBEL cell culture media analyzer. GSK will now have a total of five REBEL analyzers being used by its ...