Georg BauerDepartment Manager Foreign Affairs at TÜV SÜD, Germany
- Studied Physical Engineering at the Munich University of Applied Sciences.
- Before joining TÜV-SÜD Product Service GmbH I have been employed for more than ten years in the medical device industry holding several positions in the in the area of Quality Management and Regulatory Affairs.
- In these positions I have been responsible for Conformity Assessment and CE-mark approval of active and non-active medical devices classes I, Im, IIa, IIb and III.
- Additional responsibilities I had for medical device registrations/re-registrations and approvals outside of Europe such as China, Japan, Latin America, Taiwan, USA.
- Furthermore, I was involved in the maintenance and development of the quality management systems, preparation and participation of audits according to MDD and US FDA inspections.
- Since 9 years I am engaged at TÜV SÜD Product Service GmbH as Department Manager Foreign Affairs.
- Contact person and project handler for INMETRO Certification projects.
- We are further providing services to medical device manufacturers who intend to market their products outside of Europe, e.g. Asia, Australia, Latin America, Russian Federation, USA.