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Regulations/FDA QMSR/Actors & Services
Actors & Services · FDA QMSR

Actors & Services for FDA QMSR.

This page maps the people and service routes around the regulation. It shows who needs which evidence view and where iFeed can support review, translation, training, or readiness work without overclaiming.

Source basis: Quality Management System Regulation amendments to 21 CFR Part 820Use: evidence-readinessBoundary: not legal advice
FDA QMSR TRACE 21 CFR PART 820 SCQMSR FINAL RULE ISO 13485:2016 IFDA-SPECIFIC PRO
/ Actors

Different owners need different evidence views.

FDA QMSR
Actor 01

Head of Quality

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA QMSR.

Actor 02

regulatory affairs

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA QMSR.

Actor 03

design assurance

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA QMSR.

Actor 04

supplier quality

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA QMSR.

Actor 05

CAPA owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA QMSR.

Actor 06

document control

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA QMSR.

Actor 07

management representative

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for FDA QMSR.

/ Service fit

Where iFeed can help without overclaiming.

bridge work
Route 01

Source-to-evidence mapping

Convert source material into evidence objects, owners, gaps, and next actions.

Route 02

Checklist evaluation

Review completed readiness sheets and identify unclear or unsupported claims.

Route 03

Governance sprint

Create a practical two-week route for inventory, role mapping, evidence review, and update protocol.

Route 04

Training/workshop

Turn source reading into role-specific literacy and operational confidence.

/ Source anchors

Current public sources for FDA QMSR.

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official FDA page

FDA Quality Management System Regulation page

Current · FDA source page for QMSR background and implementation information.

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Official final rule

Federal Register final rule

2024-02-02 · Final rule amending device quality-system requirements; effective date 2026-02-02.

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Official eCFR text

21 CFR Part 820

Current · Current codified regulation text for Part 820 source checks.

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