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 ...

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 ...

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 ...

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 ...

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, ...

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...

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 ...

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 ...

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 ...