Online-Event | Validation under IVDR has become significantly more complex. This webinar outlines the new requirements for validation and performance evaluation and offers insights on what your lab needs to do.
The difficulty of risk management under IVDR lies not only in setting up a risk management file for each in-house test, but also in establishing a process for updating it over the lifecycle of the test. Labs will need to have a robust risk management process in place to meet IVDR requirements and to ensure safety and reliability for patients. This webinar provides orientation. IVDR requirements for risk management processes and documentation will be outlined, so your lab understands what it needs to do. And as always, the latest PlatoX® IVD Assistant module will be shown that enables your lab to efficiently meet the requirements in less time and with less effort. Platomics is building a comprehensive solution for documenting risk based on state-of-the-art standards and norms—tailored for lab requirements.
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