CathVision ApS, an early stage medical device company developing an 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 quality management system meets the most current regulatory requirements specific to the medical device industry. “We are very proud of this certification and it demonstrates the commitment of our global team to quality, and to meeting customer and international regulatory expectations,” said Mads Emil Matthiesen, Co-Founder and CEO of CathVision.
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.