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類別: CLASSIFICATION
作為醫療器材的軟體(SaMD)
用於醫療目的但不屬於硬體醫療器材的軟體。SaMD包括診斷算法、臨床決策支持工具和基於AI的圖像分析。受FDA、EU MDR和IMDRF指南監管。
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 作為醫療器材的軟體(SaMD) across 27 authorities in real time.
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