Introducing and implementing quality management for (AI-based) medical devices

The quality management system (QMS) of medical device manufacturers and AI system providers 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 standards EN ISO 13485 and ISO/IEC 42001, respectively.  

In this event, the realization of the project “introduction of a quality management system” will be illustrated using a fictitious model organization. We will address both the QMS requirements for medical devices and high-risk AI systems. 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)