3 Powerful Ways to Revolutionize Your Approach
to Closed-loop Quality System Traceability

An FDAnews FREE Webinar • Sponsored by Greenlight Guru
Thursday, Oct. 29, 2020 • 11:00 a.m. - 12:00 p.m. EDT

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 Will Benefit

  • Quality Professionals and Management
  • R&D Engineers and Management
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management

Sign Up for FREE Below

Meet Your Presenters

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Jason McKibbin

Former COO & Owner at MEDISISS (acquired by Medline), COO at Greenlight Guru

Before coming to Greenlight Guru, Jason was an owner-operator at MEDISISS for 13 years through the journey from a start-up to a mid-market medical device company that was later acquired by Medline Industries. After his experience with MEDISISS, he joined Greenlight Guru and has been a guiding light in the development of the business and software platform.

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Tom Rish

Senior Medical Device Guru at Greenlight Guru

Tom brings a breadth of knowledge to the Greenlight Guru team with a biomedical engineering background and experience developing implant and instrument systems for one of the world’s leading orthopedic companies.

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Taylor Brown

Medical Device Guru at Greenlight Guru

With 7+ years of industry experience, Taylor shares her valuable insights and learnings from auditing quality management systems as a certified Lead Auditor for ISO 13485 with the Greenlight Guru team and customers.