Guest user Created: Oct 19, 2018 Last commented: Oct 19, 2018

Medical Device File

I never did ISO 13485: 2016 before and I would like to know what kind of Medical device file format. Could you pls. give me some example format.

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Verlene Law Oct 19, 2018

Answer:

Medical Device File are basically a set of documentation to demonstrate the safety and performance of the device as per the intended use. There is no specific format to comply to but you should provide what is stated under clause 4.2.3 of ISO 13485.

Example of document that should be in medical device file includes but not limited to instructions for use , product labeling and product specification sheet.

For more information , please refer to:

How to meet ISO 13485:2016 requirements for medical device files
https://advisera.com/13485academy/blog/2017/06/28/how-to-meet-iso-13485-requirements-for-medical-device-files/

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Oct 19, 2018

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