Quality management for medical devices: Introduction and practical implementation

The quality management system (QMS) of medical device manufacturers serves as basis for compliance with legal provisions and, moreover, enables the organization to produce safe and reliable products for the benefit of patients and commercial success. The relevant European legislation MDR and AI Act contain concrete requirements that are at least partially fulfilled by the application of the standard EN ISO 13485.  

When the project “Introduction of a quality management system” starts in an organization, the question arises of a suitable roadmap for concrete implementation with all those involved. In this event, the realization of the project will be illustrated using a fictitious model organization. The theoretical basics will be supplemented by practical examples from the professional experience of Dr Thorsten Prinz (VDE). The event format offers sufficient time for your questions and discussions. 

The presentations will be given in German. You will receive all presentation files and example documents as PDF (in English). 

We are looking forward to your participation! 

Dr. Thorsten Prinz (VDE, Offenbach/Main)