March 07, 2024 - March 07, 2024
Date: 7 March 2024
Time: 13:30 - 17:30 CEST
Place: Noviotech Campus, Nijmegen, The Netherlands
Are you an innovative startup in the medical device, in vitro diagnostic of medtech industry and feel a bit overwhelmed by the FDA in the US?
This FDA Fundamentals course will lay out key expectations and processes required to achieve FDA clearance of your device to the US Market. It will provide direction on how and where to start with product development and ultimately, steps to preparing FDA submissions.
- Topics we will discuss are:
- Brief history of FDA - what led to creation of FDA
- FDA structure
- Device classification and general requirements
- FDA guidance documents and tips to navigate the FDA website
- Submission types - what, when, how
- Development steps leading up to a successful submission
This workshop can be the answer to the questions you have on where to start, what to do, and when to do it. In this workshop, you will learn which steps to take in which order, the key issues to address and pitfalls to avoid. Don't miss out! Join us on March 7!
For more information and to register, please visit the briskr website.