Regulatory pathway · all topics

Software as a Medical Device (SaMD) Classification

IMDRF SaMD framework classifies software based on the significance of information provided to healthcare decisions and the healthcare situation/condition. Categories I (low) through IV (high) based on intended use, ranging from informing clinical management of non-serious situations to treating or diagnosing critical situations. FDA recognizes IMDRF SaMD framework. Classification drives evidence requirements, clinical evaluation depth, and post-market surveillance plans. Distinct from Software in a Medical Device (SiMD) which is part of a hardware device.

Source

IMDRF, 'Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations' (2014)

https://www.imdrf.org/documents/software-medical-device-possible-framework-risk-categorization-and-corresponding

How MedTek OS handles this

Compass drafts the software as a medical device (samd) classification workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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