Software as a Medical Device – an introduction into Regulatory & Quality requirements

Abstract:

The medical device industry is driven by innovation, but grounded in strict regulatory frameworks designed to ensure patient safety and product efficacy. This presentation provides a comprehensive overview of the European regulatory environment, specifically the Medical Device Regulation (MDR). We will break down the complex journey of CE marking into understandable steps, starting with the basic definition of a medical device. We will look at the importance of implementing a robust Quality Management System (ISO 13485), understand the function of Notified Bodies, especially in conducting audits, as well as the role of all employees as part of this process.

About Rebekka:

Rebekka Röttger joined the Institute for Artificial Intelligence in Medicine (IKIM) in September 2025 as a Regulatory Affairs Manager. In this role, she is responsible for the development and implementation of regulatory strategies for software as a medical device, as well as the establishment of Quality Management System processes in accordance with ISO 13485. Prior to joining IKIM, Rebekka gained in-depth regulatory experience in the dental medical device industry. She holds a degree in dentistry and has extensive clinical experience as a practicing dentist.