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 ...

I clearly remember standing in the operating room (OR). I was there with our sales representative to observe a case as part of our normal Voice of Customer (VOC) process. I had seen well over 50 ...

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 ...

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...

Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers ...

Why is it necessary to develop human resources for developing medical devices? Muragaki: Medical devices tend to be over-imported, with data for 2021 showing a trade deficit of 1.8 trillion yen. In ...

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 ...

In recent years, pharmaceutical companies have broadened their horizons, moving beyond drug development to enter the medical device market. This strategic shift allows pharma to offer integrated ...