SaMD 软件作为医疗器械
- IMDRF/SaMD WG/N10FINAL:2013 Software as a Medical Device (SaMD): Key Definitions
- IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
- IMDRF/SaMD WG/N23FINAL:2015 Software as a Medical Device (SaMD): Application of Quality Management System
- IMDRF/SaMD WG/N41FINAL:2017 Software as a Medical Device (SaMD): Clinical Evaluation
- IMDRF/SaMD WG/N81 FINAL:2025 Characterization Considerations for Medical Device Software and Software-Specific Risk