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 ...

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 ...

A new guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) updates the agency's thinking on how to ensure that medical devices ...

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 ...

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 ...

Opportunities lie in offering comprehensive training on global human factors and usability regulations for medical devices, focusing on user-centered design and post-market surveillance. This ...

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 ...

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...

Dartmouth Health has launched a program aimed at preparing physicians for leadership positions related to medical device development, according to a news release shared with Becker’s. The Lebanon, N.H ...

(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 ...