FDA's quality system regulation (QSR) details specific activities that mustoccur for a new medical device to be made and commercialized in theUnited States. QSR requirements govern “the methods used ...

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 ...

A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which companies can qualify ...

In the development process of any new medical device, time to market is a key variable. Navigating through the design control process, it is likely that some aspects of a new product can leverage ...

Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success. This is an On-demand recording from July 2020.

Despite widespread and urgent therapeutic need, less than a quarter of new medical devices are developed and approved specifically for children, leaving this growing population with limited treatment ...

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 ...

(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 ...

Electronics and Telecommunications Research Institute (ETRI) of Korea and its research team have successfully developed core material and device process technologies of gallium oxide (Ga2O3) power ...