Overcome your timeline and revenue risks via a tested, fit-for-purpose solution comprised of regulatory oversight, standardized templates for technical documentation and literature search, compliant data capture and core lab capabilities to address all your IVDR needs.
TORONTO (PRWEB) November 12, 2020
The In Vitro Diagnostic Regulation (IVDR) greatly increases the number of in vitro diagnostic (IVD) devices subject to rigorous oversight and expands the scope of compliance. It brings European regulation into closer harmonization with the global classification for IVD devices that has been around for many years.
With increased requirements that include regulatory review by notified bodies, more clinical performance and evidence studies, peer reviewed literature searches and extended post marketing surveillance, many diagnostic companies are struggling with compliance in time to meet the looming May 2022 deadline, and particularly when they learn that their MDR data won’t suffice for IVDR.
Quartesian, Corgenix and their medical device partners have formed a consortium of domain experts to assess the IVDR requirements for existing devices and execute any steps necessary for compliance. Overcome your timeline and revenue risks via a tested, fit-for-purpose solution comprised of regulatory oversight, standardized templates for technical documentation and literature search, compliant data capture and core lab capabilities to address all your IVDR needs.
Join Dr. Kelly R. Pitts, President and Chief Scientific Officer, Corgenix, Inc.; and Stephen Boccardo, SVP Business Development and Commercial Strategy, Quartesian, in a live webinar on Tuesday, November 17, 2020 at 1pm EST (10am PST).
For more information, or to register for this event, visit Mind the Gap! The EU IVDR Deadline Is More Than a Regulatory Issue.
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