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 ...

At a time when medical technology breakthroughs often stall long before reaching patients, Northwestern University’s Querrey Simpson Institute for Bioelectronics (QSIB) has become a striking exception ...

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 ...

Kidd & Co-backed NexPhase Medical Devices has acquired Proven Process Medical Devices. The deal expands the platform’s expertise in R&D, engineering, design and manufacturing of FDA Class II and III ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

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 ...

Over the past year, the application of generative AI (genAI) in the Medical Instruments industry has moved from experimental to operational, transforming diagnostics, patient monitoring and ...

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

Team members with the U.S. Army Medical Materiel Development Activity joined several hundred military and medical development industry experts today to kick off the Department of Defense’s annual four ...

FORT DETRICK, Md. — The U.S. Army Medical Materiel Development Activity’s Warfighter Deployed Medical Systems and the U.S. Army Medical Test and Evaluation Activity, or USAMTEAC, recently partnered at ...