GSPR Checklist Template - IVDR 2017/746 ISO 9001 Procedure Revision Tracking: Easily identify documents

Revision Tracking: Easily identify documents due for revision

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

Set Actions and Reviews: Document the actions taken and the reviews conducted to ensure effectiveness

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Verification & Validation: Document verification and validation activities to confirm that your device meets regulatory and performance standards

GSPR Checklist Template - IVDR 2017/746 ISO 9001 Procedure Revision Tracking: Easily identify documentsGeneral 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