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)

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.


Watch the webinar

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
Who Should Attend?
      • Medical Device Executives
      • Regulatory Affairs Professionals and Management
      • Quality Professionals and Management
      • Clinical Affairs Professionals and Management 
      • R&D Engineers and Management

Hosted by

Presenter: David Amor

Medical Device QA/RA Expert

Moderator: JON SPEER

Founder & VP QA/RA, Greenlight Guru


About Rook Quality Systems

Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems by visiting their website to learn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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