10 Steps to Preparing Your 510(k) Submission (And How to Avoid the Common Pitfalls)

This webinar will focus on the key steps when preparing your 510(k) Premarket Notification and some of the common pitfalls that can occur during this process.

A 510(k) submission allows a medical device manufacturer to claim that their device is substantially equivalent to a device that is already commercially available, also known as a predicate device. It includes many components such as the device description, performance testing, and a discussion about substantial equivalence.

Choosing an appropriate predicate device, knowing how to interact with your FDA review team, and deciding what to include (and not include!) in your file are crucial components to ensure the success of your device.

During this free 60-minute webinar hosted by Allison Komiyama, Owner and Principal Consultant of AcKnowledge Regulatory Strategies, LLC, you will learn how to approach a 510(k) Premarket Notification, with considerations for potential predicates, FDA timelines, and how to avoid delaying submission review.

Specifically this webinar will cover:

510(k) Premarket Notification process and components
Timeline for 510(k) submissions
Requirements for a 510(k) submission
Common pitfalls that occur and how to avoid them
Q&A Session

Who should attend?

Medical Device Industry Executives
Quality Professionals and Management
Regulatory Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management

Presenter

allison_komiyama_round

Allison Komiyama
Owner and Principal Consultant
AcKnowledge Regulatory Strategies

Moderator

jon-speer-round

Jon Speer
Founder and VP QA/RA
Greenlight Guru

About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.

ABOUT ACKNOWLEDGE RS

AcKnowledge Regulatory Strategies specializes in Regulatory Affairs (RA) consulting exclusively for the medical device industry. When you hire us, you also hire our entire network of current and former FDA reviewers, scientists, engineers, and regulatory/quality experts. We understand that each medical device needs a specific and tailored strategy to earn regulatory clearance. We strive to work with the FDA to ease the review process and get your device on the market faster than our competitors.

Once you engage our services, we will set up a specific plan for your device or product so you have a clear understanding of what is necessary, when it’s needed, and why it’s required. Our goal is to ensure that you have well-defined expectations so we can work together to see your technology brought to market. Visit our homepage to learn more.

free On-demand webinar