This standard specifies the Quality Management System requirements that companies, operating in the
medical device industry, must implement. The implementation and certification of the ISO 13485 standard is a
prerequisite for Medical Devices and compliance with EU Regulation MDR 745/2017.
A company that complies with the requirements of the standard can obtain a Quality Management System
Certificate for Medical Devices, ISO 13485, after a successful assessment by the independent Certification
Body AXIA CERT. The Management System Certification Body AXIA CERT has been approved by the
Hellenic Accreditation System (E.SY.D.), to conduct certification audits, demonstrating the required
independence and impartiality.