Sam Brusco, Associate Editor05.24.24
Stereotaxis has received CE mark recertification under the EU’s new Medical Device Regulation (MDR) framework, which covers all the company’s devices available in Europe. Stereotaxis boasts technology for surgical robotics in minimally invasive endovascular intervention.
The new regulation has more stringent standards and requirements in quality, clinical, and post-market surveillance areas. It aims to create a robust regulatory framework to improve clinical safety and market access for medical devices in the EU.
Stereotaxis received its updated EU Quality Management System (QMS) Certificate, showing the company’s quality system aligns with MDR and granting it a valid CE mark under MDI. The company said the certification will support regulatory clearances for its upcoming innovations in the pipeline.
“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, Stereotaxis’ senior director of regulatory affairs, quality, and 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,” added David Fischel, Stereotaxis’ chairman and CEO. “Congratulations to all those at Stereotaxis who made this possible.”
Earlier this month, the company began a share purchase deal to acquire Access Point Technologies, a privately-held developer of electrophysiology catheters.
The new regulation has more stringent standards and requirements in quality, clinical, and post-market surveillance areas. It aims to create a robust regulatory framework to improve clinical safety and market access for medical devices in the EU.
Stereotaxis received its updated EU Quality Management System (QMS) Certificate, showing the company’s quality system aligns with MDR and granting it a valid CE mark under MDI. The company said the certification will support regulatory clearances for its upcoming innovations in the pipeline.
“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, Stereotaxis’ senior director of regulatory affairs, quality, and 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,” added David Fischel, Stereotaxis’ chairman and CEO. “Congratulations to all those at Stereotaxis who made this possible.”
Earlier this month, the company began a share purchase deal to acquire Access Point Technologies, a privately-held developer of electrophysiology catheters.