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Product Sample ISO 13485
Sir how long we have to save the sample product in case of ISO 13485 certified company/
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Verlene Law
Oct 11, 2018
Answer:
The Standard does not state how long the sample 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.
For more information, please refer to :
Record of Production Process Validation
https://advisera.com/13485academy/documentation/record-of-production-process-validation-iso-13485-2016/
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Oct 11, 2018
Oct 11, 2018
Oct 11, 2018