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PlatoX GSPR ASSISTANT
BRING YOUR LAB INTO IVDR COMPLIANCE
Created in collaboration with the Johner Institute GmbH consultancy, the PlatoX GSPR Assistant is a software-as-a-service that guides your diagnostic lab to IVDR compliance.
It leads you step-by-step through the General Safety and Performance Requirements (GSPRs) for each of your in-house developed tests, delivering GSPR checklist reports that can be used for audits.
Available in English or German
Complete months’ worth of regulatory work with a series of clicks. Our tool provides GSPR Checklists plus extensive guidance and answer prompts for completing them.
The GSPR Assistant is free of charge and saves your lab work hours. It also serves as a regulatory resource for your staff to prepare for the next stages of the IVDR rollout.
Created by Platomics with the Johner Institute, our software is designed to satisfy IVDR requirements for in-house tests of all risk levels. Once completed and referenced to your technical documentation, the report generated with our tool is what you need for IVDR fulfillment through May 2024.
Our experienced applications specialists are available to advise your lab on strategies for optimizing the documentation of your in-house developed workflows.
As of May 2022, EU lab should have fulfilled the first stage of the EU’s IVDR rollout. Diagnostic labs must document how they meet nearly 200 requirements and sub-requirements in the GSPR for each of their in-house developed tests.
The PlatoX GSPR Assistant is an intelligent tool that lets you:
• click your way through annotated GSPR checklists
• copy projects for similar workflows to avoid redundant work
• create an automated gap analysis
• download a report that can be used for audits
The PlatoX GSPR Assistant saves time and costs nothing.
Frequently asked questions