ISO 13485

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.

An organization/business, after a successful assessment by the Independent Certification Body AXIA CERT, receives a Certificate for Quality Management of Medical Devices, EN ISO 13485:2016. It ensures compliance with the requirements of the existing National and European Legislation concerning medical devices. It enhances customer and consumer confidence for the safety and effectiveness of the products/services. Gains added VALUE, which is undoubtedly a great competitive advantage.

This standard aims to: Healthcare Units, Manufacturers, Manufacturers, Custom Manufacturers, Importers, European Distributors of Medical Devices and In Vitro Diagnostic Products. It also concerns Technical Support Service Providers for contracts with EOPYY and participation in tenders of Public Hospitals. The application of this standard includes the design, development, production, storage, distribution, installation and maintenance of Medical Devices. An important criterion for the application of the Quality Management System is risk management that focuses on the safety and performance of the Medical Device Products and Services provided by a company and their compliance with regulatory requirements. It also calls for tighter control in the risk-based supplier evaluation process. It responds to the increased regulatory requirements for organizations throughout the Medical Device supply chain.