ISO CERTIFICATION FOR MEDICAL DEVICES

ISO 13485:2016 Quality Management System

• The company was awarded the certification ISO 13485 Quality Management System for Medical Devices in 2011.
• Currently, a clinical study with the TIES solution including up to 200 patients is ongoing to gather data on performance, usability, quality of life, health economics and showing compliance with the European Medical Device Regulation (MDR).
• The TIES Solution is the result of several years of research combined with the latest 3D manufacturing technology. It has been developed and manufactured in accordance with regulatory standards to ensure patient safety..
• OstomyCure addresses a market estimated at USD 2 billion per year.