Corporate image representing Global Certification Development Research Institute (GCDRI) delivering ISO certification ...
Several years into the process of rectifying potential breaches in the sterile packaging of its life support systems—a process that has been littered with field correction notices and FDA-rated ...
Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation ...
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced today the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood ...
This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...
As previously announced, the UK government has enacted legislation to continue the recognition of the CE marking indefinitely for a range of products falling within the scope of 21 regulations, ...
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first ...
IVDR compliance is a critical milestone not only for regulatory readiness, but for the long-term sustainability of ...
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