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FREE On-demand webinar

3 Powerful Ways to Revolutionize Your Approach to Closed-Loop Traceability

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A free, in-depth webinar covering the challenges medical device companies face today when demonstrating closed-loop traceability, the growing emphasis from industry standards and regulations, and the strategies, tactics, and tools device professionals can use to achieve truly connected quality.

For many medical device companies, processes like risk evaluations, change management, and verification relies on tribal knowledge. Achieving traceability within your quality system has historically consisted of days, weeks, or even months spent updating spreadsheets, and cross-referencing items.

Over time, the complexity of these quality systems overwhelm teams and creates enormous amounts of stress and organizational risk.

Current medical device industry standards and regulations like ISO 13485:2016, FDA 21 CFR Part 820, EU MDR/IVDR are all moving towards placing a stronger emphasis on the device maker’s ability to demonstrate closed-loop traceability throughout the Total Product Lifecycle of a quality system.

Despite this fact, our 2020 State of Medical Device Report revealed that nearly half of all medical device professionals cannot demonstrate closed-loop traceability (CLT) in their quality system. Of those that can demonstrate CLT, one in three say it takes substantial effort to do so.

This free, in-depth webcast presented by Greenlight Guru, a global leader in medical device quality management, will review how closed-loop quality system traceability facilitates a proactive and preventative approach by way of a new paradigm in how medical device companies will see, understand, explore, and communicate the world of quality.

FREE PRODUCT BONUS: Registrants will get an exclusive, in-depth look at Greenlight Guru’s latest product release - Visualize - including practical use cases, quality system optimization, and more.

 

Specifically this webinar will cover: 

  • Industry challenges and barriers to demonstrating closed-loop traceability within your quality system
  • How to overcome the common challenges to achieve the full benefits of quality system traceability
  • Purpose-built tools with the latest technologies that enable your team to achieve closed-loop traceability
  • 3 powerful ways to advance your approach to closed-loop traceability
  • How to optimize your QMS for traceability to maximize value from your quality data
  • Q&A session

Who should attend?

  • Quality Professionals and Management

  • R&D Engineers and Management

  • Medical Device Executives

  • Regulatory Affairs Professionals and Management

  • Clinical Affairs Professionals and Management

 

Presenters

jason_round

Jason McKibbin
Former COO & Owner at Medisiss (acquired by Medline)
COO at Greenlight Guru

tom-rish

Tom Rish
Senior Medical Device Guru
Greenlight Guru

 

Moderator

 Taylor Brown

Taylor Brown
Founder & VP of QA/RA
Greenlight Guru

 

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About greenlight guru

Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their 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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