Sales: 317-960-4220


How to Prepare for and Make the Most Out of Your FDA Pre-Submission: Leverage this under-utilized tool to help de-risk your 510(k)

Watch the Free On-Demand Webinar

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, 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




Medical Device QA/RA Expert


Founder & VP QA/RA

About is the only Quality Management Software Platform built exclusively for the unquie needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Go here to learn more.