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Meeting a vastly more comprehensive set of requirements
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 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.
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.
