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 ...

Holger Wagner, Head of Regulatory Affairs at Drägerwerk AG, has spearheaded transformative advancements in global compliance. With more than 17 years of experience, including a couple of years as a ...

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 ...