The FDA Pre-Submission process is one the most effective tools out there to de-risk your 510(k) yet it is often both under-utilized and used improperly.
The Pre-Sub allows for device manufacture to discuss and get feedback directly from FDA on both their product development and regulatory strategy.
When used properly the Pre-Sub process can result in significant time savings to market - however when used improperly or ignored all together, this can easily result in unnecessary delays and wasted money.
Join us for this free 90 minute webinar co-presented by David Amor, a leading medical device QA/RA expert, and Jon Speer, founder and VP of QA/RA at greenlight.guru, where the two will show you how to prepare and make the most of your Pre-Sub and also walk you through a step-by-step case study of the process.
Specifically you will learn:
- What is a Pre-Sub and why it is so important
- How to prepare and get the most out of your Pre-Sub
- The exact Pre-Sub timeline of events
- An example of the contents to include and how to format your Pre-Sub
- What you should do after your Pre-Sub
- A step-by-step case study example of the Pre-Sub process
* Note: Limited live seats available
