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Is medical device file require for a supplier ?

ISO 13485 & EU MDR
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Guest user Created:   May 27, 2019 Last commented:   May 27, 2019

Is medical device file require for a supplier ?

ISO 13485 & EU MDR
If I supply plastic injection molded clips to a medical device manufacturer am I required as a supplier to have a Medical Device file for these clips?
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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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Verlene Law May 27, 2019

Answer:

Since the plastic injected molded clips are a part of the medical device components, you have to maintain a medical device file in order to be compliant with ISO 13485.

For more information, please read article:

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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May 27, 2019

May 27, 2019

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