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
- 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 training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
The seminar deals with internationally valid standards and is also suitable for implementation abroad.
Certificate of participation from the TÜV SÜD Academy