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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

15 Steps To Get Approval To IEC 60601-1

Speed your time to market by following the step-by-step instructions, Leo the “IEC 60601-1 expert”, will discuss in this free, 90 minute webinar so you can obtain your product certification to IEC 60601-1 series of standards quicker.

Leo is going to walk you through the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.

Learn from the expert the mistakes others have made that have slowed down their certification process (and how you can avoid them).

Take proactive steps so your product doesn’t need to get redesigned after testing starts.

Watch the webinar
Specifically, you will learn:
      • The scope of IEC 60601-1 standards & if they apply to your product.
      • What you need to know to classify your products to the IEC 60601-1 series.
      • What is an isolation diagram and how does that help me with my design?
      • Determine the applicable tests for your device.
      • What are the marking and labeling requirements for the device?
      • Know your critical components.
      • What pre-tests to run and what’s not worth testing?
      • Resources to help with this process and ways to reduce the paperwork off your backs.
Who Should Attend?
      • R&D Engineers and Management
      • Regulatory Affairs Professionals and Management
      • Quality Professionals and Management
      • Medical Device Executives
      • Clinical Affairs Professionals and Management

Hosted by

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Presenter: Leonard Eisner

Principal Consultant, Eisner Safety Consultants
Jon Speer
Moderator: Jon Speer

Founder & VP QA/RA, greenlight.guru

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About Eisner Safety Consultants

Eisner Safety Consultants supports your regulatory, quality systems, product safety,
EMC, and engineering needs. Our experts speed your way to on-time product approvals via safety and regulatory agencies. We provide assistance with U.S., Canadian, European, & other international regulations. You can see a full list of the service offerings from Eisner Safety Consultants by visiting their website 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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