The In Vitro Diagnostic Regulation (IVDR) increases the number of in vitro diagnostic devices (IVD) subject to rigorous oversight and expands the scope of compliance.
With increased requirements that include regulatory review, 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.
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.
Complete this form to watch the “Mind the Gap! The EU IVDR Deadline Is More Than a Regulatory Issue” webinar immediately.