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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 Product Development Design Control Risk Management CAPA Management Audit 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 Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR
AUGUST 11, 2022

How to Ensure Your State of Affairs for EU MDR is State of the Art

While MDR does not define state of the art, it discusses state of the art in eleven instances. Further, though MEDDEV 2.7.1/4 also does not define the term, the guidance discusses state of the art 39 times. However, ISO 14971:2019 did formally define state of the art.

Register for this free, in-depth webinar, presented by Michelle Lott, Principal and Founder of leanRAQA, where we will discuss how this definition in context of the formal MDR and MEDDEV references impacts Technical Documentation, Risk Analysis, Clinical, and Post Market documentation and further rolls into the definition of standard of care.

Watch the webinar
leanRAQA Webinar 8-11-22
Specifically, this webinar will cover:
  • How to decide between building or buying a connectivity solution.
  • Written and implied definitions of state of the art across EU documents
  • Impact of state of the art on all aspects of CE marking documentation
  • Establishment and evolution of standard of care and its impact on CE marking documentation
  • Q&A session
Who should attend?
Anyone pursuing a CE mark or maintaining post market surveillance under MDR Register Now  

Hosted by

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Presenter: Michelle Lott

Principal and Founder,
leanRAQA
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Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru

 

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About 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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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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