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Product Sample ISO 13485

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Guest user Created:   Oct 11, 2018 Last commented:   Oct 11, 2018

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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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 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

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