GSPR Checklist Template – IVDR 2017 746 Cheap
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General Safety & Performance Requirements (GSPR) Checklist Template IVDR 2017 746
The General Safety and Performance Requirements (GSPR) checklist is a checklist against Annex I of the In Vitro Diagnostic Device Regulations (IVDR) EU 2017 746. The device needs to be assessed against each clause of annex I, and evidence presented on how the requirements has been met and where the evidence is located, or a justification as to why the requirement is not applicable, just writing not applicable is not sufficient. This template provides a full list of annex I clauses and formatted to easily present the data required to demonstrator conformity to the IVDR.
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