target group
Managers and employees of Regulatory Affairs.
content
The ASEAN countries, Australia, South Korea, Russia and Saudi Arabia are among the most important markets in medical technology. Before selling medical devices legally, however, manufacturers must demonstrate compliance with legal regulations. In this seminar, the participants will find out which requirements must be met in the respective countries in order for medical devices to be approved by the responsible authorities there. You will learn how to proceed in order to successfully create the necessary documentation for registration.
topic overview
- Regulatory requirements compared to Europe
- Documents to be submitted
- Competent authorities and representation in the country
- Necessary quality management systems
- Procedure & case studies
previous knowledge
Knowledge of the EU MDR and DIN EN ISO 13485 is recommended.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
