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Documenting Design History File

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Guest user Created:   Jun 28, 2017 Last commented:   Jun 28, 2017

Documenting Design History File

What is the difference between a design and development file AND a design history file (DHF)?
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ISO 9001 PROCEDURE FOR DESIGN AND DEVELOPMENT

Define the design & development process for smaller companies.

ISO 9001 PROCEDURE FOR DESIGN AND DEVELOPMENT

Define the design & development process for smaller companies.

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Strahinja Stojanovic Jun 28, 2017

If all our records are electronic (e.g. JIRA, confluence, office365) do we need to maintain a design history file (DHF)? Or can we just provide all the documents or an index of those documents?

Answer:

Design and Development File and Design History File are basically the same documents. The ISO 13485 standard requires organization to maintain this file for each medical device type or device family. It must include either records or references to them to demonstrate conformity to the requirements for design and development and records for design and development changes.

You don't have to have separate record for it, you can create database or index to all of those documents.

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Jun 28, 2017

Jun 28, 2017