46-11-22-0027
Registration of Medical Devices in the USA - Part 1 (Basic Course)
Instructor-led Training1 DayBeginnerVirtual Classroom
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
- Submission
- Access to the US market
- Product Classification
- Investigational Device Exemption (IDE)
- Premarket Approval Application (PMA)
- 510(k) Premarket Notification
- Marking/UDI
- Postmarket Requirements
- Medical Device Reporting
- Callbacks
- 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
Due to its purchasing power, the US market is one of the most important world markets for medical products. All medical devices to be distributed in the U.S. must meet the strict requirements of the U.S. Food and Drug Administration (FDA). The one-day basic course familiarizes you with the necessary basic knowledge of FDA requirements and the prerequisites for access to the U.S. market. The acquired knowledge is an effective preparation for the advanced course, in which you will learn the working method for submission and documentation.
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