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 ...

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 ...

It applies to medical devices in the early stages of development to better inform the final design of the device. It would allow studies to start earlier in the device development process than ...

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 ...

Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time ...

As medical devices become increasingly more complex, the need to enhance development efficiency, quality by design, integrated risk management, and regulatory compliance has never been greater ...

Dartmouth Health has launched a program aimed at preparing physicians for leadership positions related to medical device development, according to a news release shared with Becker’s. The Lebanon, N.H ...