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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 CAPA Management Audit Management Product Development

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

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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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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FREE ON-DEMAND WEBINAR

What You Need To Know About Life With FDA After Your Device Gains Clearance

Getting your device approved or cleared by FDA is a critical step, of course, but it's only the beginning of your relationship with US federal regulatory agencies.

In this free 60 minute webinar, we will examine the ongoing FDA compliance obligations a device manufacturer has to deal with after PMA approval or 510(k) clearance.

It will cover issues that impact both domestic and international device companies.

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Specifically, you will learn:
      • What you should know about FDA inspections
      • An overview of Quality System Inspection Techniques (QSIT)
      • QSR and design issues that may surface in the domestic production or importation of devices or components
      • Understanding the intersection between FDA and US Customs
      • What does you company need to do if things do go wrong with FDA

Hosted by

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Presenter: John Johnson III

Senior Associate Attorney, benjaminlengland.com
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Presenter: Thomas Knott

Senior Regulatory Advisor, FDAImports.com
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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About FDAImports.com
Importing medical devices into the highly-regulated markets of the United States can be confusing, complex, and costly. This is particularly true if you do not have an experienced team of professionals to give you confidence that your products and your facilities meet all applicable federal & state regulatory requirements. FDAImports.com and its sister law firm, Benjamin L. England & Associates help clients from over 100 countries in every aspect of FDA, USDA, and Customs compliance. Visit fdaimports.com to learn more about their services. 

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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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