GSPR Checklist Template - IVDR 2017/746 ISO 9001 Procedure Traceability: Ensuring traceability of design

Traceability: Ensuring traceability of design and development outputs to inputs

and root causes

The extent of this verification should be based on your assessment of suppliers and the risks associated with the product

Corrective Action involves steps to reduce or eliminate the cause of a reported non-conformity or inefficiency in your Quality Management System

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GSPR Checklist Template - IVDR 2017/746 ISO 9001 Procedure Traceability: Ensuring traceability of designGeneral 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