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CATEGORY: CLASSIFICATION
Software as a Medical Device (SaMD)
Software intended to be used for medical purposes without being part of a hardware medical device. SaMD can include diagnostic algorithms, clinical decision support tools, and AI-based image analysis. Regulated under FDA, EU MDR, and IMDRF guidance.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Software as a Medical Device (SaMD) across 27 authorities in real time.
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