ISO 13485 Quality management system for medical devices


ISO 13485 Quality management system for medical devices

ISO 13485 is dedicated to organisations involved in the design, manufacture and packaging, as well as the import of medical devices. It contains the management system requirements and is intended for organisations wishing to demonstrate their ability to provide medical devices and related services.

The primary objective of the standard is to facilitate the harmonisation of medical device regulatory requirements with quality management systems.

Benefits of ISO 13485 implementation and certification:
compliance with legal requirements, including the Medical Devices Act,
increasing the company’s prestige,
increasing the competitiveness of the organisation on the domestic and foreign markets,
increasing customer trust.

We offer effective development and implementation of a Quality Management System for medical devices based on the highest competence and experience of our consultants.