• Pharmaceutical / Biotechnology / Biologics
• Medical Device
  • Manufacturing
  • Clinical Trials
  • Sales and Marketing
  • Supply Chain / Subcontractor Management
  • Ethics and Corporate Responsibility
  • Case Studies
• Health Care
• Energy
• Engineering & Construction
• Manufacturing & Services
• Government & Non-Profits

Kaplan EduNeering provides medical device companies with the same proven solution used by the US FDA to train federal, state, and local inspectors. We work with companies specializing 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 comply with US and international regulations, assure product quality throughout the supply chain, and gain operational efficiencies through effective centralized management of dispersed operations. A comprehensive library of online resources that are authored or reviewed by the FDA provides role-based regulatory training for medical device personnel working 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 audit-ready, centralized transcript using ComplianceWire®, Kaplan EduNeering'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, enabling the automatic generation of targeted learning as employees join the company, assume new roles in the company or retraining is needed to meet annual requirements or regulatory information is updated.  Since our solution is offered via the Software as a Service (SaaS) approach, compliance programs are easily extended to your external suppliers, subcontractors, and sales agents. 

Unique Industry Partnerships

In addition to our ongoing relationship with FDA, Kaplan EduNeering 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.