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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 CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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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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FREE ON-DEMAND WEBINAR
September 5, 2023

How to Validate an Electronic Data Capture Setup for a Medical Device Clinical Investigation

System validation and study setup validation are integral to maintaining the highest standards of quality and regulatory compliance in the medical device industry.

While these two processes differ in scope, they are equally important. In this free webinar, we explore key differences between system validation and study validation and why they are both foundational to creating and maintaining high-quality, effective, and safe medical devices.

Join us and discover best practices to validate an EDC system as well as your study setup to avoid discrepancies, compliance issues and ensure data integrity and accuracy.

 
 

Watch the webinar
GG_ST_Validation Webinar 09-05-2023
Specifically, this webinar will cover:
  • System Validation vs. Study (setup) Validation (UAT)
  • IQ vs OQ vs PQ
  • Why a pre-validated system saves time and resources
  • Study Validation templates, SOPs, WIs
Who should attend? 
  • Clinical Affairs/Operations Professionals & Management
  • Regulatory Affairs Professionals & Management
  • Medical Device Executives
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Hosted by

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Moderator:
ETIENNE NICHOLS

Medical Device Guru,
Greenlight Guru
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Presenter:
RASMUS BLENDAL

Product Manager,
Greenlight Guru Clinical
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Presenter:
KIMBERLEY LAU

Solutions Engineer,
Greenlight Guru Clinical

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About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.

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