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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 Supplier 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 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

Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)

For medical device companies, the ability to efficiently manage, control, and document changes are necessary to minimizing both patient and business risk.

Greenlight Guru founder Jon Speer will discuss how you can establish a change control process to ensure internal consistency throughout your quality management systems and documentation.

By effectively monitoring the inter-dependencies of documents in your QMS you’ll have an easier time identifying documents that are affected by a change and maintaining consistency within the quality documentation. Find out how by watching this free webinar presented by Greenlight Guru founder and VP of QA/RA, Jon Speer.

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Specifically, this webinar will cover:
  • Streamlining the change control process: A step-by-step guide
  • The different types of change and how to manage each (with case examples)
  • A risk-based approach to change management: Avoiding pitfalls that compromise quality
  • Managing change at every step: Solving challenges of the changing product lifecycle
  • Making friends with technology: Cutting-edge solutions to controlling, planning, documenting and implementing change
  • Q&A Session
Who Should Attend?
  • Medical Device Industry Executives
  • Quality Professionals and Management
  • Regulatory Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
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Hosted by

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Presenter: Jon Speer

Founder, VP of QA/RA, Greenlight Guru

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Presenter: Craig Rotzler

FDAnews

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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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About FDA News

EWCG’s FDAnews gives regulatory and quality executives the most thorough, up-to-date understanding of inner workings at the FDA and EMA and how they’re likely to alter your development and manufacturing strategies. If you’re looking to ensure successful regulatory inspections and audits, you’ll value our 483s database, webinars and conferences on manufacturing quality assurance, compliance and risk mitigation.

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