Content
The seminar gives participants an overview of the markets and market volume in medical technology. The roles of the “International Authorized Representatives” and the assumption of responsibilities in selected markets, including an overview of the approval processes, are clarified. Participants will also receive information on post-market surveillance as well as the involvement and legal responsibilities of the “international authorized representatives”.
Topic overview
- Overview of markets and market volumes in medical technology
- Overview of conformity assessment procedures and classifications as the basis of the seminar (with a focus on the 5 MDSAP markets as well as other relevant sales markets)
- Role definition “International authorized representative” and assumption of responsibilities in selected markets, including an overview of the approval processes
- Differentiation from other roles in the regulatory environment of medical technology
- Presentation of special tasks (for the first time) as well as ongoing rights and obligations of the authorized representative (regularly)
- Post-Market Surveillance and the involvement and legal responsibilities of the “International Representative”
target group
Employees in quality management and regulatory affairs as well as employees in export and sales for international medical technology companies.
Prior knowledge
Basics, better specialist knowledge of regulatory principles and the marketing of medical devices. Understanding of roles in the regulatory world of medical devices.
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:
TuttlingenTuttlingen & Online
