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Greenlight Guru’s eQMS platform and UL’s ComplianceWire® compliance training and learning management system (LMS) deliver solutions for long-term success.

Purpose-built platform for medical device companies

Built-in controls that align with 21 CFR Part 820 and ISO 13485:2016.

Flexible review and approval workflows with Part 11 compliant audit trail and e-Signatures.

Fully integrated Design Controls and Risk Management aligned to ISO 14971.

LinkAnything drives full lifecycle traceability.

Zero-effort system validation.

Drive collaboration with task management, comments, and notifications.

Combination medical devices

Bring safer, better medical devices to market faster

Create and update your traceability matrices in minutes, not hours or days. Then easily export records on demand.

Generate design history files without searching for the required documentation.

Save time with Part 11 compliant e-signatures, flexible review and approval workflows, revision control, and more.

Keep your risk management file up to date and avoid costly rework by mitigating potential risks.

Remote usability studies

Advance the success of your devices already on market

Remain compliant and manage risk in the face of ISO and FDA changes.

Identify CAPAs, discover their root causes, resolve them, and report outcomes.

Manage feedback and complaints, escalate when appropriate, and update your risk management file.

Conduct internal audits and always be ready for external audits and inspections.

ComplianceWire® training is a proven solution for medical device manufacturers

UL’s best-in-class web-based platform designed specifically for highly regulated industries.

Automates the creation, delivery, and reporting of role-based training, qualification, and compliance programs.

Renowned as the “gold standard” learning management system (LMS) for the life sciences.

Used by the US FDA since 1999 to train more than 40,000 investigators.

Provides a comprehensive approach to regulatory compliance

LMS technology makes it easy to create and automate compliance training programs.

Library of over 1,000 e-learning training modules.

Catalogs containing over 500 courses specific to life sciences.

110 courses developed jointly by the US FDA and UL.

Prompt, personalized support delivered by expert training professionals.

Fully compliant with 21 CFR Part 11 and EU Annex 11 validation requirements

Users receive validation summary reports, Part 11 white papers, audits with UL quality experts, and validation test scripts.

Sort employees into training groups based on criteria such as job function.

Automated version control lowers the risk of human error.

Built to support AICC and SCORM learning content.

Courses designed to meet the diverse needs of learners worldwide.

Generate your own training content with UL’s design team or the course self-authoring tool, Create.

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Ready for the next step?