Quarem Resources

For AI-enabled medical devices, three regulatory frameworks now apply simultaneously. Understanding what each requires, and where they overlap, is the starting point for any compliance strategy. If your organization develops or markets AI-enabled medical devices in the European Union, you are now operating under three overlapping regulatory frameworks: the Medical Devices Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746), the EU AI Act (Regulation (E

For companies developing medical device software (SaMD), regulatory success depends on more than just following a single standard. It requires the seamless integration of three distinct frameworks: ISO 13485 (Quality Management), IEC 62304 (Software Lifecycle), and ISO 14971 (Risk Management).