Declaration of Conformity Template - IVDR 2017/746

ISO 13485 - QMS.4.2.3.1.1 - Declaration of Conformity Template - IVDR 2017/746

The declaration of conformity is a statement made and signed by the legal manufacturer that they have met all the regulatory requirements stated within the regulation. This template meets the required information needed on a declaration of conformity to medical device regulation EU 2017/746.

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