In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement ...

PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...

Opinions expressed by Digital Journal contributors are their own. “In the face of rapid technological progress, the real challenge lies in aligning our supply chain to match the resilience and ...

Editor’s note: Nicholas Webb, the author of this article, is scheduled to be the opening keynote speaker at MD&M West, North America’s most comprehensive manufacturing trade show focusing on the ...

Apple's engineers are researching how to best make a series of standardized enclosures that would allow users to routinely swap batteries between higher-powered devices like an iMac, and lower powered ...

Hospitals have relied on nasogastric tubes for decades — but Solventum’s version of the product has changed everything for nurses, patients and their families. As a clinical applications engineer at ...