The EN 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.
We have developed and implemented our 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 EN ISO 13485:2016 accreditation demonstrates our commitment to providing high-quality and consistent products and services to our clients, while taking this route we also prepare ourselves for the new Medical Device Regulation (MDR).
To become EN ISO 13485:2016 compliant, Duomed Scandinavia underwent a screening process to determine any gaps, from here on we started to develop a completely new Quality Management System. Within 12 months all management system documentation was ready for review and passed both the initial and main audit assessment.
The EN ISO 13485:2016 certification is the assurance that we need in order to work according to the latest standards and regulations, also so that we can assure you as our partner that we have robust, clearly defined procedures in place
Our Quality Department is happy to give you an answer to additional questions.
Contact them by sending a e-mail to quality.dk@duomed.com