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Is medical device file require for a supplier ?
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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
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
May 27, 2019