Mind the Gap! The EU IVDR Deadline Is More Than a Regulatory Issue

The In Vitro Diagnostic Regulation (IVDR) greatly increases the number of in vitro diagnostic devices (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.

Speakers

Dr. Kelly R. Pitts, President and Chief Scientific Officer, Corgenix, Inc.

Dr. Kelly R. Pitts is President and Chief Scientific Officer at Corgenix, Inc., a 35-year-old in vitro diagnostics company with a fully integrated R&D organization emphasizing regulatory compliance, product lifecycle management, and quality improvement. Dr. Pitts has held scientific leadership positions at biotechnology and biopharma companies such as Myogen, Inc., Gilead Sciences Inc., and Amgen, Inc. Dr. Pitts earned a BS in Biochemistry from Brigham Young University, a PhD in Biomedical Sciences from the Mayo Clinic, and is a patent agent registered with the USPTO.

Message Presenter

Stephen Boccardo, SVP Business Development and Commercial Strategy, Quartesian

Stephen Boccardo combines more than 30 years of life science industry experience and dedicated technology expertise with a record of growing startup organizations through sales and marketing leadership. Boccardo joined Quartesian from Clinical Ink, where he served as Chief Commercial Officer. Prior to that, he was at BioClinica and Bio-Pharm Clinical Services (OmniCare) and began his career as a clinical data programming manager at SmithKline Beecham. Boccardo holds a master’s degree in computer science from Villanova University and a BS in mathematics from Ursinus College.

Message Presenter