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 ...

The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...

The medical device industry is larger and more innovative than ever. Clinical research is experiencing a surge of innovation ...

Way back in 2001, MD+DI published an article detailing what the author considered to be The Seven Deadly Sins of Medical Device Development. The author reviewed dozens of device development programs ...

The Master of Engineering (M.Eng.) in Medical Device Development is a cutting-edge program that promises to accelerate the career development of aspiring engineers in all disciplines who wish to pivot ...

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 ...

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 ...

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 ...

Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a need for speed, how do companies stay ahead without cutting corners?

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 ...