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Ang release of Product

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Guest user Created:   Sep 17, 2021 Last commented:   Sep 20, 2021

Ang release of Product

Which document in the ISO 13485 toolkit dictate release of product and who is responsible for releaseing? Cant seem to find it

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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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Kristina Zvonar Brkić Sep 20, 2021

There is no direct requirement for the release of the product. There is only in the requirement 7.5.8 Identification following requirement:

"The organization shall identify product status with respect to monitoring and measurement requirements through product realization. Identification of product status shall be maintained throughout production, storage, installation, and servicing of the product to ensure that only  product that has passed the required inspections and test or released under an authorized concession is dispatched, used, or installed."

So here is stated that release of the product must be controlled, but who will be that is up to the manufacturer.

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Sep 20, 2021