Registration of Medical Devices in the USA - Part 1 (Basic Course)
Medical devices successfully approved in the USA:
- You will acquire detailed knowledge of the approval requirements for the distribution of your medical devices in the USA.
- You will get to know the structures of the FDA.
- We will show you how to gain access to the US market for medical devices.
Manufacturers and exporters of medical devices
- Legislative and regulatory overview
- Overview of legislation
- Organization of the FDA
- General FDA Requirements
- Registration and Listing
- Access to the US market
- Product Classification
- Investigational Device Exemption (IDE)
- Premarket Approval Application (PMA)
- 510(k) Premarket Notification
- Postmarket Requirements
- Medical Device Reporting
- Device Tracking
- QM Requirements USA 21CFR 820
- Overview and definitions
- Procedure of an FDA inspection
- Possible consequences of the inspection
- FDA Fees
- 510(k) Third Party Review Program
Instructor-Led Virtual Classroom.
- This seminar is part of a modular training. After successful participation in the advanced modules, you can acquire this recognized degree:
- Manager Regulatory Affairs International – TÜV
- The seminar deals with internationally valid standards and is also suitable for implementation abroad.
Certificate of participation from the TÜV SÜD Academy