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 ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

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 ...

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 ...

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 ...

Search for requirements management tools for medical device development and you’ll find plenty of content arguing that the established platforms are too heavy for modern teams. Much of it comes from ...

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 ...

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 ...