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Stereotaxis Receives CE Mark Recertification


Stereotaxis has announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe.

MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed the approval and marketing of medical devices in the EU. The new regulation includes more stringent standards and requirements across quality, clinical and post-market surveillance areas. It is intended to create a robust regulatory framework for improved clinical safety and market access for medical devices. Stereotaxis has now received its updated EU Quality Management System Certificate. This certificate shows that the Stereotaxis Quality System is in accordance with MDR and that Stereotaxis’ products now have a valid CE Mark under MDR. This MDR certification will support regulatory clearances of upcoming innovations.

“This final step in the certification of our products and quality systems under MDR is the culmination of several years of diligent work by the Stereotaxis team,” said Matthew Stepanek, Sr. Director of Regulatory Affairs, Quality & Technical Writing. “We appreciate the collaboration with our Notified Body in this entire process.”

“This is a reflection of Stereotaxis’ commitment to high-quality devices, systems, and processes to ensure the best possible experience for the patients and physicians that rely on our technology,” said David Fischel, Chairman and CEO. “Congratulations to all those at Stereotaxis who made this possible.”

Source: Stereotaxis 

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