Documenting Design History File
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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