How long to keep prosthesis product in the even of knee transplant
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Answer:
The Standard does not state how long a product should be kept. Generally, it should follow applicable regulatory guidelines or the projected useful life of the medial device depending on whichever is the longest. In this case, there should be documented records for traceability of the prosthesis in case of any field safety notice and recall.
For more information , please refer to
How to manage recalls and advisory notices for medical devices according to ISO 13485
https://advisera.com/13485academy/blog/2017/08/31/how-to-manage-recalls-and-advisory-notices-for-medical-devices-according-to-iso-13485/
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Oct 16, 2018