DUBLIN, May 23, 2019 /PRNewswire/ -- The "The Medical Device Summer School - From Concept to CE Marking" conference has been added to ResearchAndMarkets.com's offering From concept to CE marking - ...

Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took ...

Zap-X, a gyroscopic radiosurgery robot developed and manufactured by Zap Surgical, received a CE mark in 2021 under the European Union’s Medical Device Regulation (MDR). Zap Surgical CEO John Adler, ...

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 ...

The Company’s designated Notified Body confirmed dates for conducting audits for ISO 13485 certification to ensure Microbot complies with the QMS requirements of the EU MDR The Company expects that ...