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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

EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

In May of 2017 the European Union’s Medical Device Regulation came into force and with that came a three year transition time which ends on May 26th, 2020.

But despite the fact that we’re over 50% of the way through the transition, there continues to be anxiety and confusion surrounding how to interpret the European MDR, what it means to each organization and what you can do to be compliant in the EU.

Watch the webinar
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Specifically, this webinar will cover:
  • Understanding the key dates, timelines and limitations related to the EU MDR
  • Learn which QMS processes were affected by the regulations and what portion of the EU MDR and ISO 13485:2016 they relate to
  • Learn about the different workflows for conformity assessments of all classes of medical devices (I, Im, Is, Ir, IIa, IIb, III)
  • Be aware of the work that needs to take place to be compliant and ready for May 26th, 2020
  • Discuss key actions related to EU MDR transition strategies based on industry experiences.

These topics and more will be discussed in our free, live webinar presented by Brian Hockett of R&Q Solutions.

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
 Register Now  

Hosted by

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Presenter: Brian Hockett

Project Engineer, Regulatory and Quality Solutions LLC (R&Q)
Jon Speer
Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About R&Q

R&Q provides regulatory and quality solutions that accelerate the success of medical device companies and improve people’s lives. It exists to promote economic growth through regional partnerships, to provide a rewarding place to work, and to improve our communities. Learn more about and connect with the R&Q team 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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