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Engineering Change Notice Procedure — editable word document cover

Engineering Change Notice Procedure | ISO 13485 | FDA QMSR

$149.00Price

Control changes to medical device specifications, procedures and affected materials with this editable ISO 13485 Engineering Change Notice (ECN) Procedure and forms. It guides change initiation, cross-functional approval, inventory and work-in-process disposition, implementation, technical-documentation impact review and closure.

ISO 13485:2016 Engineering Change Notice Procedure

The Engineering Change Notice (ECN) Procedure defines the process to create, modify, or obsolete controlled documents within the company in accordance with GMP and ISO 13485:2016 requirements.

 

The Engineering Change Notice Procedure governs the entire ECN process including responsibilities for originator and approvers, required approvals per document type.

 

The Engineering Change Notice Procedure includes detailed forms divided by Sections. The ECN form includes:

  • Coversheet and Summary Information

  • Documents and Locations Affected by Changes

  • Materials Affected and Disposition of Inventory, WIP, Open P.O.'s

  • Method of Implementation Options

  • ECN Content Checklist to Guide Originator

  • Checklist for assessing the effect of changes on technical documentation

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

 

Use the ECN workflow with the Document Control Procedure for issuing, tracking and archiving approved revisions.

When an approved change affects the manufacturing file, see the Device Master Record and Technical Documentation Procedure. Both are included in the Document Control Procedure Bundle.

Supplied as editable Microsoft Word documents with related forms in a digital download.

Part of a procedure bundle

This document is also included in ISO 13485 Document Control Procedure Bundle. Explore the bundle for the related documents.

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