Content
Canada, Brazil, Mexico and Australia are emerging as promising consumer markets. As with the EU, the authorities there require various documents for approval. In this seminar, participants will learn about similarities and differences to CE certification. You will also receive an overview of the documents to be submitted.
Topic overview
- Derivation and presentation of the regulatory requirements in the respective countries
- Requirements for the quality management system
- Approval dossiers
- Competent authorities and representation in the country
- Process and case studies
target group
Managing Director and Employee Regulatory Affairs.
Prior knowledge
Knowledge of the EU MDR and DIN EN ISO 13485 is recommended.
Notice
Participation in the seminar “Fundamentals of Regulatory Affairs International” is recommended in advance.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Tuttlingen & Online
