The International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force (GHTF), has released two new consultations regarding its ...
With the demise of the Global Harmonization Task Force-a regulatory harmonization body focused on medical devices-in 2012, much attention has been paid to its successor, the regulators-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 ...
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 ...
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