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A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which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

A medtech expert explains that concurrent development reduces costly delays in complex medical device programs.

As technology continues to improve and change all aspects of our lives, digital transformation is starting to emerge as a C-level objective in the medical device space. Data and tech enablement have ...

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 ...

THY Precision delivers medical injection molding and medical device assembly services in ISO-certified cleanroom for ...

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 ...

Eclypsium security researchers have uncovered UEFI vulnerabilities in the Illumina iSeq 100 DNA sequencer, but the broader issue involves the device development process at large. In highlighting ...