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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR
August 8, 2019

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.

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AKomiyama webinar - Preparing your 510k-1
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
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Hosted by

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Presenter: Allison Komiyama

Owner and Principal Consultant, AcKnowledge Regulatory Strategies
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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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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. 

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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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