Registration of Medical Devices in the USA – Part 2 - FDA 510(k) (Advanced Course)
Medical devices successfully approved in the USA:
- You will acquire detailed knowledge on how to prepare a 510(k) application.
- You will get to know the requirements for market access in the USA.
- We give you insight into how to use 510(k).
- Manufacturers and exporters of medical devices
- Employee Regulatory Affairs
- Employee Product Development
- Security administrator
- Employee Quality Management
- 510(k) Premarket Notification Requirements
- Basics
- Abbreviated – Special 510(k)
- De-Novo Process
- Biocompatibility
- Software Security
- Design changes
- 510(k) Practice
- Creation and submission of your own 510(k)
- Strategy and error prevention
- Best Practice
Due to its economic strength and size, the US market is one of the most important global markets for medical devices. To distribute your products in the U.S., you must meet the requirements of the U.S. Food and Drug Administration (FDA). Building on the basic course, the advanced course deepens your knowledge. We will introduce you to the requirements when creating a 510(k) application. Because not only the first export of a medical device requires a 510(k) "clearance", but often also the modification of an existing medical device. It is precisely this procedure and the decision criteria for submitting an amendment that are explicitly discussed.
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
Successfully completing the Registration of Medical Devices in the USA - Part 1 (Basic Course).