Formulario de contacto tel:(+34) 91 432 60 00

Quality Management Systems in Medical Devices UNE EN ISO 13485

It details the UNE EN ISO 13485 certification, which ensures quality and safety in the management of medical devices in accordance with European regulations

Request information

Quality in medical devices

The UNE EN ISO 13485:2018 standard is the European version of the ISO 13485:2016 standard, specifically adapted for compliance with regulatory requirements in Europe. This international standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to manage medical devices and services, which consistently meet customer requirements and applicable regulations.

UNE EN ISO 13485 does not introduce substantial changes with respect to its previous version, but represents the adoption and adaptation of the ISO standard for the European context.

AENOR has been accredited by ENAC to certify quality management systems according to the UNE-EN ISO 13485:2018 Standard. The scope of AENOR's accreditation includes non-active medical devices (e.g. heart valves, breast or hip prostheses), active non-implantable medical devices (such as defibrillators), medical devices for in vitro diagnostics, as well as associated parts, parts or services. This accreditation recognises AENOR's technical competence and independence, backed by more than 100 certificates in force in several countries, and which reinforces its ability to audit with rigour and objectivity, guaranteeing safety and quality in the healthcare sector.

Quality Management System Certificate for Medical Devices

ISO 13485 sets out requirements for quality management systems in medical devices, ensuring patient safety and regulatory compliance. Promotes continuous improvement and operational efficiency

Request information

The main elements of the UNE EN ISO 13485 standard include:

Risk management-based approach
Legal and regulatory compliance
Control of Suppliers and Subcontractors
Documentation and Records Management
Control of Monitoring and Measurement Equipment: Approach to Software Validation
Focus on Continuous Improvement
Staff Training and Awareness

Brand IQNetMANAGEMENT SYSTEM

The IQNet RECOGNIZED CERTIFICATION mark guarantees that an organization complies with international standards of quality and management. This recognition facilitates confidence and competitiveness in the global market

Request information

Related Industries

Certification in accordance with this Standard is applicable to all organisations in any sector involved during the useful life of a medical device in the activities of design, manufacture, packaging, drafting and/or translation of instruction manuals, advertising, sales, distribution, training for use, and installation or maintenance.