The ISO 13485:2016 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

RT-IDea EU developed and implemented a quality management system in order to make sure that we have indicated all possible risks towards patient safety, plus also taken the necessary measurements to avoid them. Our decision to work towards the ISO 13485:2016 accreditation demonstrates our commitment to providing high-quality and consistent products and services to our users, while taking this route we are ready for the new Medical Device Regulation (MDR) per May 26, 2020.