IVDR is a marathon, not a sprint. We’ll help you go the distance.
Like many other ideas that are intended to improve existing products or procedures, the new European IVD Regulation (IVD-R) 2017/746 road is paved with good intentions. However, some of these intentions may potentially render the daily life of clinical flow cytometry laboratories a lot more complex than what they are now, due to the latest regulations for Laboratory-Developed Tests (LDTs).
We at Beckman Coulter Life Sciences are partnering with you and support you with the largest available portfolio of CE-IVD and IVDR compliant reagents in the market and support you in your patients' journey in order to bring transparency into this important change.
IVDR Readiness Webinar
Watch webinar on potential impact of IVD-R on the daily life of the clinical Flow Cytometry laboratory by Maurizio Suppo, PhD, an expert in IVD industry regulation.
Impacts of IVDR on Clinical Flow Cytometry
This article will provide a broad coverage of the new EU IVD Regulation and will specifically elaborate on how the EU authorities will regulate the vast majority of the Laboratory-Developed Tests (LDTs).
Meet the Expert
Maurizio has more than 34 years of experience in the field of regulatory affairs and quality systems in the In-Vitro Diagnostic industry.
IVD-R Annex I Global Safety and Performances Requirements (GSPR)
The IVD-R undoubtedly increase complexity for IVD products, including LDTs, to be compliant.
Validation of Flow Cytometry Assay According to ISO 15189
Each laboratory must define which parameters must be validated in the context of its IVD experiments and the norms it needs to comply with, and it must define an optimal protocol to achieve its objectives.
IVDD vs IVDR Infographic
Learn more about changes coming to Laboratory Developed Tests regulation from our infographic.
Future proofing your flow cytometry panel under IVDR
In this webinar Pieter Bogaert, Senior Expert for Device Compliance at Qarad BV, gives an overview about the options clinical labs have to future proof their flow cytometry panels in the context of IVDR.