From the Expert
Closing the Postmarket Loop: A Unified Strategy for US QMSR and EU MDR Compliance
Navigating divergent postmarket requirements between US FDA and the EU’s Medical Device Regulation often creates redundant, disconnected Quality Management Systems. This article, from AngioSafe quality and regulatory expert Khushbu Shah, presents a unified lifecycle risk framework that integrates user hazard analysis, failure mode and effects analysis, and proactive signal detection to satisfy both regulatory bodies through a single, risk management file.
