FREE On-demand webinar

Prepping your QMS for EU MDR

Watch the Free Webinar


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.

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

 

Presenter

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Kyle Rose
President
Rook Quality Systems

Moderator

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Jon Speer
Founder & VP QA/RA
Greenlight Guru

 

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About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.

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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. To see a full list of the services Rook offers you can go here.

 

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