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 ...

Medical Device Audit Program Needs More Industry Involvement, Report Says A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be ...

Medical device manufacturers face a labyrinth of audit and inspection regimes, each with unique demands that can make global compliance feel like a high-stakes balancing act. This article examines the ...

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