In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important deadlines, exceptions and the main differences in the way these tests will be overseen on these two continents.Please...
Technology Landscape and Challenges of High Throughput vs. POC Diagnostics
As the world is beginning to understand, SARS-CoV-2 poses several unique challenges. Asymptomatic and infected individuals are highly contagious and present unprecedented viral transmissibility. As countries and markets try to fully understand the economic impact of...
White Paper: Introduction to EU Artificial Intelligence Act
[dpvfw_pdf_viewer_embed pdfviewer="8913" _builder_version="4.18.0" _module_preset="default" link_option_url="https://veranex.com/wp-content/uploads/2024/03/White-Paper_EU-AI-in-healthcare.pdf" global_colors_info="{}"...
White Paper: How Clean is Clean Enough?
The importance of developing, implementing, and validating a cleaning process and its potential impact on sterilization validation and biocompatibility[dpvfw_pdf_viewer_embed pdfviewer="9332" _builder_version="4.18.0" _module_preset="default"...