to In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR). Historically, IVD devices could be self-assessed under the 1998 Directive, meaning that manufacturers could declare that the device was ...
Medical devices comprise electronic equipment, implants, consumables and disposables, surgical instruments and in-vitro ...
an in vitro diagnostic medical device that harnesses AI to generate heatmaps identifying small and rare missed prostatic cancers, acting as a safety net that assists pathologists in ensuring patients ...
Emboa Medical has developed a novel blood clot extraction device to address the prevalent issue of stroke, which is the second leading cause of death in the world. Using nature-inspired design, Emboa ...
The global in vitro diagnostics (IVD) market encompasses a wide range of medical devices, reagents, and testing methodologies used for diagnosing diseases and monitoring patient health outside of the ...
The goal is to improve patient safety by monitoring, recording, and analysing the root cause of adverse events or risks associated with the use of medical devices, including in-vitro-diagnostics.