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

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 ...

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 ...

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 ...

Developing a drug delivery device system (combination product) adds a layer of complexity to your pharmaceutical program that many companies underestimate until it's too late. Success depends not just ...

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

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 ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...