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