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A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which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

Nine requirements management tools for medical device development ranked by traceability, compliance support, and regulatory readiness for FDA and EU MDR.

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 ...

Reproducing results obtained in a compound semiconductor device development lab is especially challenging at scale because ...

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 ...

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 ...