Chapter 09 · Updates & Assets

Updates & Assets as a reviewable surface.

The updates and assets layer keeps MedTech / SaMD alive through weekly signals, source maps, checklists, explainers, and revision notes.

Focus: intended use · device claim · surveillanceRisk: uncontrolled changeBridge: QMS · evidence · post-market record
MedTech / SaMD traceClaimQMSModelPCCPUserSurveilAIsystemsource to workflow to evidence to review
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Updates & Assets chapter.

MedTech / SaMD

The updates and assets layer keeps MedTech / SaMD alive through weekly signals, source maps, checklists, explainers, and revision notes.

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What this page maps.

operating content
Weekly signal shelf

Weekly signal shelf

Stores source-backed updates that change understanding, risk, or operational work.

Reusable assets

Reusable assets

Turns learning into checklists, source maps, readiness questions, and outreach material.

Revision discipline

Revision discipline

Dates every change and separates source fact from iFeed interpretation.

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Governance questions.

review logic
Question

What decision or record does this updates & assets surface influence, and who owns that decision?

Question

Which evidence is needed before routine use in MedTech / SaMD, and where is it retained?

Question

What signal triggers review, restriction, escalation, or retirement?

/ evidence

Evidence-ready minimum record.

iFeed use
Minimum record
OwnerNamed operational, clinical, technical, and governance owners.
UseClear intended use, user group, workflow point, and excluded use.
RiskRisk tier, rationale, residual risks, controls, and escalation route.
EvidenceSource claims, validation basis, limitations, approval decision, and review date.
/ sources

Source anchors and claim boundary.

official first

These 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.