Regulated AI & Compliance

A 21 CFR Part 11 and ISO 13485 Compliant Electronic Document Management System

Electronic document management for AI-as-a-medical-device development

The paperwork backbone of a regulated medical-AI product: controlled documents with signatures, approvals and a full audit trail.

The problem

AI-as-a-medical-device teams must control every document under 21 CFR Part 11 and ISO 13485, and spreadsheets and shared drives cannot prove who approved what, and when.

The approach

An EDMS with a structured QMS hierarchy and versioning, electronic signatures, multi-stage approval routing and an audit trail, driven by a workflow engine that enforces Draft, Review, Approval and Approved with role-based reviewers and approvers.

The outcome

Part 11-controlled document management that supports ISO 13485-aligned quality systems.

In detail

Built a full electronic document management system for controlled documents across a structured quality-management hierarchy, with versioning throughout. It implements the 21 CFR Part 11 controls (electronic signatures, multi-stage approval routing and an audit trail) and a workflow engine that enforces Draft, Review, Approval and Approved states with role-based reviewers and approvers, supporting ISO 13485-aligned documentation for AI-as-a-medical-device development.

Built with

• 21 CFR Part 11
• ISO 13485
• QMS
• Workflow Engine
• Audit Trail

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By Kanishka Ranaweera, PhD, Machine Learning Engineer in Melbourne, Victoria, Australia. hello@kanishkabuilt.me