ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.2.1: Determination of requirements related to product

The organization determines the requirements specified by the customer including delivery and post-delivery activities, requirements not stated by the customer but necessary for the specified or intended use as known, applicable regulatory requirements related to the product, any user training needed to ensure specified performance and safe use of the device, and any additional requirements the organization determines.

Maintained by Gerard BlokdykControl text last updated

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