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 ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

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 ...

Medical devices can be designed to ease their use and minimize the potential for errors. Here are four ways human-centered ...

Opinions expressed by Digital Journal contributors are their own. Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a ...

Bringing a medical device to market is about much more than demonstrating that it performs its intended purpose.

The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...

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 ...

China's National Medical Products Administration (NMPA) on Monday approved the release of its third medical device standard ...

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 ...