FDA Fundamentals

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. Don’t miss out! Join us on March 7!

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

Speaker:

Lorry Weaver, MLS(ASCP), CLS, Principal Consultant, Regulatory Affairs

Qserve Group, US

Location
Noviotech Campus Nijmegen, building M, Meet&Greet area. Transistorweg 5

Good to know
The workshop is facilitated in English. Participation in the workshop is free for everyone, including drinks and bites. However, for cancellations within 24 hours prior to the event, we will charge a fee of 15 euros (excluding VAT) to cover expenses.