Device Master Record and Technical Documentation Procedure

The Device Master Record and Technical Documentation Procedure defines the creation and content of the documentation used for manufacturing a finished medical device.

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Supplied as one editable Microsoft Word document in a digital download.

Manufacturing specifications and device documentation

It addresses the Device Master Record and technical documentation summary, helping organize the manufacturing documentation associated with the finished device.

The medical device file terminology in ISO 13485:2016 clause 4.2.3 provides the current QMSR context for this documentation. Device Master Record (DMR) remains a useful organizational term; the former standalone 21 CFR 820.181 requirement is no longer the current citation.

The procedure describes how the device master record and technical documentation bring together the device description, components, manufacturing information, packaging, labeling, applicable safety and performance evidence, and risk and clinical records. Engineering and quality or regulatory functions review the specifications before approval. The document helps teams identify which controlled design outputs belong in the production record and which supporting evidence belongs in the technical file.

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.

For controlled changes to manufacturing specifications and technical documentation, use the Engineering Change Notice Procedure and Document Control Procedure. These procedures are included with this document in the Document Control Procedure Bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Production Records, Line Clearance and Shipment for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

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