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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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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

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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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FREE ON-DEMAND WEBINAR

Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment

In the wake of MDR, the topic of notified bodies has received quite a bit of negative attention...and for good reason.

There’s been a substantial reduction of notified bodies designated under MDD to MDR…

Originally 126 to now just 23 notified bodies currently designated under MDR, to be exact.

As a result, the EU go-to-market journey is fraught with roadblocks. It’s no wonder that increasing contention exists between notified bodies and manufacturers.

In this free in-depth webinar presented by regulatory expert Michelle Lott, president of Lean RAQA, participants will get the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and challenges they are facing during this transition period.

Register now to unlock the powerful knowledge Michelle will share about her lessons learned working alongside notified bodies and manufacturers and the do’s and don'ts every manufacturer must know if marketing a medical device in the EU market.

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Lean RAQA + GG webinar - 12-2-21
Specifically, this webinar will cover:
  • Provide real life examples from products going through this transition period
  • Identify areas where industry is consistently making mistakes from the Notified Body perspective
  • Review appeals pathways or other options if opposing opinions arise
  • Provide valuable insight on how industry can align with the expectations of Notified Bodies under MDR
Who Should Attend?
  • Any industry representative that is either in the EU now or intends to pursue commercialization in the EU market
    • Medical Device Executives
    • Regulatory Affairs Professionals and Management
    • Quality Professionals and Management
    • Clinical Affairs Professionals and Management
    • R&D Engineers and Management

  • Learning level: Intermediate
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Hosted by

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Presenter: Michelle Lott

Regulatory Strategist, Principal and Founder
Lean RAQA
Taylor Brown
Moderator: Taylor Brown

Senior Medical Device Guru, Greenlight Guru

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About Lean Raqa

At Lean RAQA, our mission is to deliver medical device Regulatory and Quality system solutions customized to your business needs. Regulatory strategy, quality systems, and submissions are not one size fits all. Clients get practical, sustainable solutions that meet their business needs without creating undue burden. For more information, please visit their website by clicking 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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