You are already familiar with the standards and laws for implementing an effective quality management system at a medical device manufacturer. ISO 13485:2016 (in the version published in 2021 as DIN EN ISO) as an internationally recognized standard is the basis of your work in the medical technology world. You will be familiar with the link between the European Medical Device Regulations MDR and IVDR and the ISO standard and their importance for a continuously functioning QMS.

In the second 5-day module of our training course, you will acquire the qualification as a quality management representative in the medical device industry in accordance with ISO 13485:2016. This will expand your methodological and technical expertise and show you how you can implement your knowledge quickly and effectively in your company. As part of group work, you will learn how to set up, maintain, and continuously develop a QM system in the medical device industry in compliance with standards and legislation. 

As a QM representative, you are the central point of contact for all matters relating to medical device quality management, not only internally for employees and management, but also for external bodies such as certification bodies/designated bodies and competent authorities. 

An excellent add-on is an advanced qualification as a quality auditor, which you can acquire in the third part of this modular training course.