Stefan Bolleininger

Stefan Bolleininger is a renowned expert in the field of medical device regulation, particularly within Europe. He is the founder and CEO of be-on-Quality GmbH, a consulting agency dedicated to supporting manufacturers through the complexities of CE and FDA approvals. His expertise spans the entire spectrum of quality and regulatory requirements, including implementation, maintenance, audits, assessments, and inspections.  Stefan is also a key opinion leader and speaker on the Medical Device Regulation (MDR) in Europe. He holds a teaching assignment at the Technical University of Nuremberg, where he focuses on risk management and usability for medical devices and networks. Additionally, he is a member of the VDI Technical Committee on “Quality Assurance for Software in Medical Devices” and member of the ethics commitee of the FAU University Erlangen