You are well familiar with the world of medical technology with its numerous standards and laws, including the worldwide demand for an effective quality management system in the manufacture of medical devices. ISO 13485:2016 as an internationally recognized standard and its link with the European MDR or MDR regulations. IVDR are the basis of your daily work. They know about the extensive requirements, for example that the promised medical benefit should function continuously in compliance with all legal requirements. In everyday business, you have already successfully implemented and managed the quality management system for medical devices. As a quality management officer in the medical device industry according to ISO 13485:2016, you know that audits are an indispensable component for the success of your quality management system.

Now it's time for the third step: In our 5-day seminar, you will learn to audit in accordance with the requirements of ISO 13485:2016. To do this, you will deepen your knowledge of the contents and objectives of DIN EN ISO 19011:2018. In this training we will teach you everything you need to know about the planning, implementation and follow-up of audits in quality management according to ISO 13485. You will train all professional and personal skills in intensive group work and audit simulations. In an expert feedback you will be shown your strengths and potentials. This gives you the necessary security for your appearance as a quality auditor in order to be able to subsequently work as an auditor in the medical device industry.