Juanito Created: Aug 31, 2017 Last commented: Sep 01, 2017

Device Master File Documentation & Record Control

Hi! Please help me to my concerned. What is the meaning of DHF/Batch records. I'm not familiar to this DHF meaning. This DHF/Batch records is in the audit plan of are upcoming auditor but I did not know what is this. Thank you.

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Strahinja Stojanovic Sep 01, 2017

DHF is abbreviation for Design History File which is a formal document that is prepared for each medical device. The DHF can be either a collection of the actual documents generated in the product development (PD) process or an index of documents and their storage location.

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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Aug 31, 2017

Sep 01, 2017

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