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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

The Pre-Market Approval (PMA): Is it really as bad as so many think?

The premarket approval (PMA) is the second most commonly used pathway to market for medical devices in the US. In fact, nearly 10% of devices are brought to market using this pathway.

Yet 70-90% of PMA’s are rejected by FDA upon first review (MDUFA) – why? This should be an embarrassing statistic for our industry as most of these rejections are not only preventable, they are predicable!

Since the PMA is reserved for “high risk” (class III) devices, the requirements are more complex compared to more common 510k.

However, the regulatory logic used to prepare a PMA, 510k, de novo or any other regulatory submission is exactly the same.

This presentation will emphasize the regulatory logic to design a successful PMA submission while discussing some of the common pitfalls experienced during the PMA process.

Watch the webinar
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Using a case study approach, you will learn:
  • How to decide whether to use the PMA or another pathway to market?
  • How can the PMA be your friend (e.g., when a PMA is actually preferred over a 510k)?
  • What sub-types of PMAs exist and how to decide which to use when?
  • What are the ‘required contents’ of a PMA submission?
  • Can we use “substance equivalence” in the PMA?
  • When can we combine pathways via label expansion: HDE to PMA
  • How to use the PMA beyond the device world? i.e., using combination products: PMA+NDA / PMA+BLA, etc.
  • What’s changing in the PMA world, i.e., pre-/post-market requirements, reporting requirements, etc.

Although this course will focus on US requirements, suggestions on how to leverage your data with international submissions will also be discussed.  Simply put: when used appropriately, the PMA can offer significant advantages to the manufacturer.  But if you’re not careful, you might be asked to do much more than what is necessary!  

In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the PMA to their advantage! 

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
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Hosted by

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Presenter: Mike Drues

President, Vascular Sciences
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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About Vascular Sciences
Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn 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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