Data Substrate as a reviewable surface.
The data substrate for MedTech / SaMD determines what the model can know, what it misses, what it amplifies, and what remains reviewable later.
Data Substrate chapter.
MedTech / SaMDThe data substrate for MedTech / SaMD determines what the model can know, what it misses, what it amplifies, and what remains reviewable later.
What this page maps.
operating contentSource data
Defines origin, consent or authorization, quality status, context, exclusions, and transformation history.
Lineage
Keeps the chain visible from source record to model input, output, human review, and final action.
Monitoring fields
Captures use, overrides, errors, drift, incidents, feedback, and review outcomes.
Governance questions.
review logicWhat decision or record does this data substrate surface influence, and who owns that decision?
Which evidence is needed before routine use in MedTech / SaMD, and where is it retained?
What signal triggers review, restriction, escalation, or retirement?
Evidence-ready minimum record.
iFeed useSource anchors and claim boundary.
official firstThese anchors support the source layer for this page. iFeed interpretation remains separate from source facts and does not replace legal, regulatory, clinical, or product-specific advice.