GSPR Checklist Template - IVDR 2017/746General 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

consumer complaints

Continuous Improvement: Leveraging customer feedback to improve your products and Quality Management System

supporting regulatory compliance and product quality assurance

ISO 9001:2015 QMS Template - Training & Qualification Procedure (QMS

or to provide feedback

This template provides a standard format to ensure your MRMs are documented correctly and in compliance with ISO 13485

making it the perfect solution for companies starting a Quality Management System (QMS) from scratch

Ensure Product Compliance: Verify that design outputs meet regulatory

which states: “The specific approach and activities associated with software validation and re-validation shall be proportionate to the risk associated with the use of the software

Ensure Compliance: Maintain a structured approach to internal auditing that meets ISO 9001 standards

Reduce Waste and Downtime: Minimize production losses due to equipment being out of service

only QMS procedures