CathVision recently received ISO 13485:2016 certification for its medical device and quality management system from Lloyd’s Register.
“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,” Mads Emil Matthiesen, cofounder and CEO of CathVision, said in a press release.
The new ISO certification ensures that the company’s quality management system meets current regulatory requirements that are specific to the medical device industry.
“This certification represents an important milestone for our company and reflects our rigorous and risk-based approach to development and commercialization,” said Andreas Pfahnl, CathVision’s CTO and president.