On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...

Three months in, most medical device manufacturers have completed their initial gap assessments — but the harder work is only ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...

The FDAs new QMSR quietly created a harmonized quality framework between the U.S. and Latin America. With high recruitment ...

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.

The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA ...

Nathan Eddy works as an independent filmmaker and journalist based in Berlin, specializing in architecture, business technology and healthcare IT. He is a graduate of Northwestern University’s Medill ...

"A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the ...

Quality control is often still a manual process, particularly in medical device manufacturing. Vision inspection technology can help automate inspection, but manufacturers still face challenges.