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IVDReady your
lab for compliance
by May 2024

Our unique program takes your lab
on a 12-month guided trek to reach
IVDR compliance for your in-house tests

IVDReady is a free one-year program that navigates labs to full compliance for the next phase of IVDR requirements pending on May 26, 2024. We offer a structured path forward with monthly webinars and cost-free use of our compliance tool, PlatoX® IVD Assistant.*

*Registration and use of IVD Assistant is free of charge for health institutions for the purpose of IVDR documentation of in-house tests.

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By now, all labs are to have fulfilled the General Safety and Performance Requirements. And by May 2024, a vastly more comprehensive set of requirements must be met for each in-house diagnostic test.

The IVDReady Program offers labs:

  • Cost-free use of PlatoX® IVD Assistant for creating the entire set of IVDR technical documentation for in-house tests, including wizards, templates and rules-based automation for generating content.
  • Monthly webinars and regular activities that walk you through the strategy and know-how needed for meeting the requirements, from standards to intended purpose and clinical use surveillance.
  • Guidance and information from our in-house regulatory experts plus guest speakers.
    Access to the required IVDR documentation from our manufacturer partners for common lab components including sequencers, reagents, reference materials, etc.

Benefits for labs

Save time and effort

Our platform’s wizards, templates, automation and knowledge-base make it quicker and easier to document your in-house tests.

Get guidance

The program offers expert support for the full range of IVDR documentation, with monthly activities to keep you on schedule for bringing your lab to compliance by May 2024.

Reduce costs

The IVDReady Program and use of IVD Assistant for IVDR technical documentation of in-house tests are free of charge for health institutions including clinical labs.

Data security

Our data for IVD Assistant is stored in an ISO 27001-certified external data center in Vienna. We respect the requirements of the GDPR and do not transfer any data to third countries lacking the level of protection required by the GDPR. 

Certificate

Receive certificates from Platomics for participation in IVDReady webinars and for completing IVDR documentation steps on our platform.

IVDReady webinar series

IVDReady by May 2024 with
Platomics

Jun 20, 2023

Our kick-off webinar introduces
IVDReady, a free one-year program
that guides labs to full IVDR compliance.

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1. Let’s talk strategy

Jul 6, 2023

The first thing your lab needs is a strategy for documenting workflows
— whether you’ve got 50 or 250 in-house tests.

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2. Give it a purpose

Jul 25, 2023

Ready to start documenting an in-house test? It all begins with the intended purpose.

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3. Perplexity is the
beginning of knowledge

Aug 29, 2023

This webinar outlines the regulatory knowledge base available to you through the IVDReady program and our regulatory platform, PlatoX IVD Assistant.  

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4. Gate Opening: Introducing the
Workflow Studio

Oct 12, 2023

Here we’ll show how our Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.

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5. GSPRs are challenging, standards are beautiful

Jan 30, 2024

GSPRs are challenging, and therein lies the beauty of established standards: they are state-of-the-art and as such can reliably fulfill the GSPRs. Find out what your lab needs to do and how best to get it done.

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6. An ounce of validation

Mar 12, 2024

We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.

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7. The real risk is not managing risk

April 30, 2024

Labs will need to have a robust risk management process in place to meet the requirements and ensure safety and reliability for patients. This webinar will provide orientation.

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8. IVDReady To Go

July 9, 2024

Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including up to date information about the final phase of implementation.

Watch now