Description
Stefan Bolleininger is a prominent figure in the field of medical device regulation and quality management. He is the founder of be-on-Quality GmbH, a consulting agency dedicated to supporting medical device manufacturers in obtaining CE and FDA approvals. His expertise spans across various aspects of quality and regulatory requirements, including implementation, maintenance, audits, assessments, and inspections. Stefan is a key opinion leader and speaker on the Medical Device Regulation (MDR) in Europe. He is actively involved in the VDI Technical Committee for "Quality Assurance for Software in Medical Devices" and holds a teaching assignment at the Technical University of Nuremberg, where he focuses on risk management and usability for medical devices in is also in the ethics committee of the university of Erlangen. In addition to his consulting work, Stefan is an author and trainer, contributing to the development of best practices for medical device software development. His dedication to the field has made him a respected authority in ensuring the quality and safety of medical devices.
