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Content of the Design History File

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Guest user Created:   Oct 05, 2017 Last commented:   Oct 05, 2017

Content of the Design History File

Can you please give me an example to constitute a design file, I need to have at least a summary in accordance with the new requirement of the standard iso 13485.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Oct 05, 2017

Answer:

The design history file is an FDA term which you’ll find described in 21 CFR Part 820.30. It talks about your design controls and how they must be kept in a design history file. Design History File (DHF) is simply the collection of documents from the design and development process.

Here’s how the FDA describe it in 21 CFR Part 820.30(j):
“Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of this part.”

Until recently, a DHF was technically only a requirement defined by FDA. ISO 13485:2003 made no direct mentioned of a DHF, or something similar. However, the updated ISO 13485:2016 does now specify the need to establish “design and development files”.

For more information, see : How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/
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Oct 04, 2017

Oct 04, 2017