Companies that trade medical devices are required by virtue of Ministerial Decision Ε3/833/1999 to have their Quality Management System certified. ISO 13485:2003 is based on the principles of ISO 9001:2008 and is specially designed for medical device companies. The aim of this Quality Management System (QMS) is to ensure:
The benefits of the adoption of a Management System are the following:
The aim of our company is to design a fully customised, simple and effective system that serves as a true “tool” for improvement.