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

Traceability: Ensuring traceability of design and development outputs to inputs

The Declaration of Conformity is required to be uploaded onto the EUDAMED system for EU market access

and Resources: Identifying necessary procedures

This template should give you a clear overarching view to quicky identify that you are meeting the requirements of risk management for medical devices within your risk management file and medical device technical documentation

Enhance your Quality Management System with our ISO 13485:2016 compliant Non-Conformance Report Log template

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