As for the IVDR, in January 2022 the Council and the European Parliament had already decided on a general extension of the transition period (as applicable to certificates) to 26 May 2025, with ...

CE-marked under the EU IVDR regulation, Diagnostics.AI's platform is the first to deliver AI algorithmic transparency and per-test auditability for clinical PCR diagnostics As the May 26th CE-IVDR ...

Join the one-day course to master the Person Responsible for Regulatory Compliance (PRRC) role under MDR 2017/745 and IVDR 2017/746. Gain insights into Article 15, UK MDR, and integration into ...

The IVDR registration certifies that the SOPHiA DDM™ Platform's genetic analysis meets the European IVDR 2017/746 requirements, which govern the sale of in vitro diagnostic devices within the ...

IVDR is a set of regulations that came into effect on May 26, 2022 that were put in place by the Europe Union (EU) to ensure the safety, traceability, quality and performance of in-vitro ...

Join the one-day course to master the Person Responsible for Regulatory Compliance (PRRC) role under MDR 2017/745 and IVDR 2017/746. Gain insights in ...

As the May 26th CE-IVDR compliance deadline comes into effect, Diagnostics.ai launches the industry’s first fully-transparent machine learning platform for clinical real-time PCR diagnostics ...

The introduction of the Person Responsible for Regulatory Compliance (PRRC) role mandated under the Medical Device Regulation (MDR) 2017/745 and the In-vitro Diagnostic Device Regulation (IVDR ...