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 ...

“Anyone doing design, development, or postmarket surveillance for a medical product that humans use should be considering human factors and usability,” Shannon Hoste, chief scientific officer at ...

Innovation identifies a better way to meet an unmet need; the quality system makes that improvement reproducible, traceable, ...

A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which companies can qualify ...

Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success. This is an On-demand recording from July 2020.

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

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 ...

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 ...

Asia-Pacific Holds Largest Medical Device CDMO Share; Europe Emerges as Fastest-Growing CDMO MarketDublin, Aug. (GLOBE NEWSWIRE) -- The "Medical Device CDMO - Market Share Analysis, Industry Trends & ...

TOLEDO, Ohio and DURHAM, N.C., April 30, 2026 /PRNewswire/ -- NAMSA, the global leader in MedTech contract research offering end-to-end development services, today announced a strategic partnership ...