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 ...

WASHINGTON, DC—In an effort to increase understanding of the medical device development process and help companies execute the bench-to-bedside process of product development more effectively, ...

Learn how CDMO partnerships can help medtech engineers streamline development and ensure manufacturing excellence.

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 ...

When development efforts aren't well managed, appropriately documented, or realistically planned, a company's most innovative product ideas might never make it to market. Brian Kelleher By some ...

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 ...

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 ...

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 ...

Major processes in semiconductor wafer fabrication: 1) wafer preparation, 2) pattern transfer, 3) doping, 4) deposition, 5) etching, and 6) packaging. The process of creating semiconductors can be ...

As medical devices become increasingly more complex, the need to enhance development efficiency, quality by design, integrated risk management, and regulatory compliance has never been greater ...

(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 ...