Remove Contamination Remove FDA Compliance Remove In-Vitro
article thumbnail

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

Food and Drug Administration (FDA): Oversees the safety and effectiveness of medical devices in the United States. European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). What is the Medical Device Safety process?