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Regulations/AI MedTech / SaMD/Actors & Services
Actors & Services · AI MedTech / SaMD

Actors & Services for AI MedTech / SaMD.

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: AI/ML-enabled device software, SaMD, and change-control guidanceUse: evidence-readinessBoundary: not legal advice
AI MedTech / SaM TRACE FDA AI/ML SAMD HUBFDA PCCP GUIDANCFDA LIFECYCLE-MAFDA AI-ENABLED D
/ Actors

Different owners need different evidence views.

AI MedTech / SaMD
Actor 01

regulatory affairs

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for AI MedTech / SaMD.

Actor 02

software lead

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for AI MedTech / SaMD.

Actor 03

ML/data science

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for AI MedTech / SaMD.

Actor 04

clinical safety

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for AI MedTech / SaMD.

Actor 05

human factors

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for AI MedTech / SaMD.

Actor 06

post-market surveillance

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for AI MedTech / SaMD.

Actor 07

QA/RA approver

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for AI MedTech / SaMD.

/ 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 AI MedTech / SaMD.

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 AI Software as a Medical Device page

Current · FDA landing page for AI-enabled software as a medical device.

open
Official FDA guidance

FDA PCCP guidance for AI-enabled device software functions

2024-12-04 · Guidance on marketing submission recommendations for predetermined change control plans.

open
Official FDA draft guidance

FDA AI-enabled device lifecycle draft guidance

2025-01 · Draft lifecycle management and marketing submission guidance. Treat as draft/watch item.

open
Official regulator principles

FDA/Health Canada/MHRA GMLP principles

2021-10-27 · Ten guiding principles for machine-learning-enabled medical device development.

open