COPENHAGEN, Denmark, October 2, 2018 /PRNewswire/ --
CathVision ApS, an early stage medical device company developingan advanced cardiac electrophysiology recording system, CUBE, announced today that the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd's Register. This ISO certification indicates that the company's
ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product. "This certification represents an important milestone for our company, and reflects our rigorous and risk-based approach to development and commercialization," said Andreas Pfahnl ScD, CathVision's CTO & US President.
Headquartered in Copenhagen, Denmark with its US business office in Minnesota USA, CathVision is developing a medical device to treat atrial fibrillation and cardiac arrhythmias. The solution is a comprehensive intelligent software platform that is built around a low-noise recording system to provide exceptional EP signals for identification and characterization of arrhythmias. Visit http://www.cathvision.com for more information.
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