In 2019, Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP), replacing the Canadian Medical Devices Conformity Assessment System (CMDCAS). All ...
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 ...
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 ...