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Greenlight Guru QMS

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

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Featured Capabilities:

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

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

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

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

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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FREE ON-DEMAND WEBINAR

FDA 510(k) Submission Insider Tips, Tricks and Timelines from a Former FDA Reviewer

Did you know that between January and June of 2015, 69% of 510(k) applications were rejected their first time?

Even though there have been significant changes to the content required in a 510(k) submission since the agency released their guidance in 2005, this should not be the case.

So what can you do to better manage your team’s 510(k) expectations?

How can you piece together your submission in a way that’s least likely to be rejected?

Join us for this free, 60 minute webinar, presented by our guest Allison Komiyama, PhD, RAC, principal consultant at AcKnowledge Regulatory Strategies and a former FDA reviewer.

Allison will be sharing with you some of her insider tips and best practices so you have a better chance at receiving your clearance letter faster than your competitors!

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Specifically, this webinar includes:
      • Insider tips, tricks and best practices to getting your device to market faster
      • What exactly are the expectations for your 510(k)?
      • What does the 510(k) timeline look like and how long is it going to take?
      • How to avoid having your 510(k) rejected
      • What happens to your 510(k) once it’s submitted to FDA?
      • What does the 510(k) pathway really look like?
      • How to prepare your 510(k) submission
Who Should Attend:
      • Medical Device Presidents and CEOs
      • Regulatory Affairs Professionals and Management
      • Quality Professionals and Management
      • Clinical Affairs Professionals and Management 
      • R&D Engineers and Management

Hosted by

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Presenter: Allison Komiyama, PHD, RAC

Principal Consultant, AcKnowledge Regulatory Strategies
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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About AcKnowledge Regulatory Strategies

AcKnowledge Regulatory Strategies was started by Allison Komiyama, Ph.D, R.A.C., in order to serve clients who manufactures implantable and other patient-contacting medical devices. To see a full list of the services AcKnowledge offers you can go here.

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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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