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UL provides medical device companies with the same proven solution used by the FDA to train federal, state and local inspectors. We work with companies that specialize in orthopedics, endoscopy, implantables, combination products, vision care and laboratory equipment to assure regulatory compliance, product quality and patient safety.
21 CFR Part 11-Validated Learning Management System
Our technology-based solutions deliver knowledge resources to help companies comply with US and international regulations, assure product quality throughout the supply chain and improve efficiency through effective centralized management of dispersed operations. A comprehensive library of online resources that are authored or reviewed by the FDA provide role-based regulatory training for medical device personnel who work on the design, clinical evaluation, manufacture or promotion of medical technology.
Other requisite knowledge ranging from SOPs to corporate codes of conduct may be distributed, tracked, and documented in an audit-ready, centralized transcript using ComplianceWire®, UL's hosted 21 CFR Part 11-validated learning management system.
Enterprise-wide Compliance Management
ComplianceWire® interoperates with other key business systems, including human resources information, document management and ERP systems. This allows for automatic generation of targeted learning when employees join or assume new roles in the company, retraining is needed to meet annual requirements, or regulatory information is updated. Our solution is offered via the Software as a Service (SaaS) approach, so you can easily extend to your external suppliers, subcontractors, and sales agents.
Unique Industry Partnerships
In addition to our ongoing relationship with the FDA, UL serves as AdvaMed’s exclusive online compliance partner, providing its members with educational resources to maintain regulatory compliance and professional knowledge. Those programs accommodate the needs of both emerging companies and well-established device firms.
Global Regulatory Compliance Learning
Addressing International Regulatory and Corporate Compliance Requirements