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 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 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 ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

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 ...

Given that medical devices are becoming increasingly complex, it is often hard for developers to stay op to date with evolving real-world parameters (human factors) and regulatory standards. Moreover, ...

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 ...

ProMed, a contract manufacturer specializing in liquid silicone rubber (LSR) and highly regulated combination products, has announced new process refinements in the LSR injection molding process ...