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Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

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

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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FREE ON-DEMAND WEBINAR
February 9, 2023

MDR by the Numbers: Leveraging New Data for Implementation Planning

After the wake of the initial and then the first extension of the MDR deadline, the EU regulatory landscape is still reeling from the new requirements.

Now facing the possibility of another extension, the medical device industry is further confused not only about requirements themselves but also if and when they must comply.

MDR by the numbers now:

  • 8,120: Number of applications
  • 1,990: Number of certificates issued
  • 7,000: Number of certificates that may be issued in total by May 2024
  • 22,793: Number of certificates under MDD set to expire by May 2024
  • 425,000: Number of devices under said MDD certificates that will no longer be available after May 2024 without drastic and immediate action

Register for this free webinar for an in-depth look at MDR implementation by these cold, hard numbers.

You'll learn from regulatory strategist Michelle Lott, Principal and Founder of leanRAQA, as she presents the results of research on recent MDCG guidance, industry and Notified Body surveys, and personal interviews with stakeholders (including Notified Bodies) on first hand experiences with implementation with a goal to bring advice on the process to the forefront.

Watch the webinar
LeanRAQA webinar 2-9-23-1
Specifically, this webinar will cover:
  • Where MDR stands today - an extensive look at published data from competent authorities, notified bodies and industry stakeholders
  • Review of recently published MCDG guidances
  • Nuances of the MDR "Extension"
  • What medical device professionals need to be doing
Who should attend? 
Medical Device Professionals, Industry Stakeholders Register Now

Hosted by

Brittani Smith
Moderator:
Brittani Smith

Medical Device Guru,
Greenlight Guru

MIchelle Lott 300x300
Presenter:
Michelle Lott

Principal and Founder,
leanRAQA

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success. Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk. Visit our homepage to learn more.

leanRAQA logo_compact transparent background - Michelle Lott

leanRAQA

leanRAQA is an end-to-end service provider for regulatory and quality activities for the US, EU and other global markets. Visit their website to learn more.

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