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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

Prepping your QMS for EU MDR

According to a recent survey conducted by KPMG & RAPS,

  • Nearly 80% of respondents currently lack sufficient understanding of the MDR
  • The number of potential notified bodies has dropped by 75%
  • More than 60% of companies believe quality requirements to be most challenging for EU MDR compliance

We've teamed up with Rook Quality Systems to share their expertise on the topic and provide critical steps needed to prepare your Quality Management System for the upcoming EU Medical Device Regulations in 2020.

This in-depth webinar will cover some of the most important action items that must be taken ASAP by companies, and we'll help you understand what you need to get started.

Watch the webinar
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Some of the changes we will cover include:
  • Updates to Complaint Handling and Vigilance
  • Documentation and requirements for each category of Economic Operators within the supply chain
  • Updates to comply with SPRs
  • Incorporating UDI and EUDAMED into your labeling and traceability SOPs
  • Procedures for the regulatory compliance strategy
  • New requirements for Implantable devices
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: Kyle Rose

President, Rook Quality Systems
Jon Speer
Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About Rook Quality Systems

Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems 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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