ISO 13485

ISO 13485:2016

Quality Management System for Medical Devices

UDEM Adriatic d.o.o. is accredited by the Croatian Accreditation Agency for the certification of quality management systems for medical devices according to ISO 13485:2016.

The scope of our accreditation is available at the following link.

ISO 13485:2016 is an internationally recognised standard that defines requirements for a quality management system for organisations involved in one or more stages of the life cycle of a medical device. The standard is intended for medical device manufacturers, as well as organisations providing related services, including design and development, production, storage, distribution, installation, servicing and other related activities.

ISO 13485:2016 is based on quality management system principles, but includes specific requirements relevant to the medical device sector. Particular emphasis is placed on regulatory requirements, risk management, process control, traceability, documented information, supplier management, process validation, handling of nonconformities, corrective actions and the safety of medical devices.

Key elements of ISO 13485:2016 include:

  • compliance with applicable regulatory requirements;
  • risk management throughout the life cycle of the medical device;
  • control of design and development;
  • control of production and service provision;
  • validation of special processes, where applicable;
  • control of suppliers and externally provided processes;
  • traceability of medical devices;
  • management of documentation and records;
  • handling of complaints and feedback;
  • control of nonconforming products;
  • corrective and preventive actions;
  • maintaining the effectiveness of the quality management system.

Certification according to ISO 13485:2016 helps organisations demonstrate their ability to consistently meet customer requirements and applicable regulatory requirements for medical devices. It also supports organisations in establishing a reliable and effective quality management system adapted to the specific requirements of the medical device sector.