Chapter 08 · Market & Actors

Market & Actors as a reviewable surface.

The market and actor layer for MedTech / SaMD maps who builds, sells, deploys, uses, monitors, audits, and regulates the capability.

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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Market & Actors chapter.

MedTech / SaMD

The market and actor layer for MedTech / SaMD maps who builds, sells, deploys, uses, monitors, audits, and regulates the capability.

/ A

What this page maps.

operating content
Actor map

Actor map

Developer, vendor, platform provider, deployer, user, quality owner, regulator, standard body, and assurance provider.

Buyer lens

Buyer lens

Procurement questions focus on evidence, service responsibility, change notification, data use, audit support, and limitations.

Market signal

Market signal

Partnerships, pilots, acquisitions, guidance, and product launches are read through evidence and governance impact.

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Governance questions.

review logic
Question

What decision or record does this market & actors 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.