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Download your Medical Device File creation & maintenance procedure

Adopt and adapt our expertly designed procedure for building a technical file (word format)

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A fully configurable procedure template for creating a Medical Device File

A medical device technical file is the collection of documents that contains all the information required for ISO 13485:2106, EU MDR/IVDR and FDA QSR compliance.

This document breaks down the required contents of the technical file (known in the US as the Device Master Record).

Use it to demonstrate to regulators and notified bodies how you will structure and maintain the file throughout your product’s lifecycle.


Outlines a formal process for structuring your medical device file

Outlines a formal process for maintaining your medical device file

Uses the STED file format as specified in GHTF/SG1/N011:2008

Serves as a configurable template for every new device that you create when used with Cognidox

Download your template now