← 所有术语
类别: CLASSIFICATION
作为医疗器械的软件(SaMD)
用于医疗目的但不属于硬件医疗器械的软件。SaMD包括诊断算法、临床决策支持工具和基于AI的图像分析。受FDA、EU MDR和IMDRF指南监管。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Software as a Medical Device (SaMD) performs medical functions without being part of a hardware device—regulated under FDA, EU MDR, and IMDRF principles with software lifecycle controls (IEC 62304).
PROCESS / STEPS
- Determine medical intended purpose and classification.
- Apply software lifecycle, cybersecurity, and clinical evaluation appropriate to risk.
- Select premarket path (e.g., 510(k)/De Novo/CE route).
- Plan postmarket monitoring for model drift and safety signals.
EXAMPLES
- AI imaging triage tools and clinical decision support with diagnostic claims.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 作为医疗器械的软件(SaMD) across 27 authorities in real time.
START FREE →