Welcome to the AdvaMed Regulatory & Compliance Certificate Program

Designed for Medical Technology Professionals

Today’s Medical Technology organizations demand mastery of specific regulatory compliance and quality issues to remain competitive.

The AdvaMed Regulatory & Compliance Certificate (ARCC) Program offers three separate program options (tracks) and leverages UL Quality, Compliance and Learning's extensive online libraries, including both FDA and AdvaMed-approved content. Each track includes 3-4 required courses and 6-7 electives, selected to meet specific regulatory requirements for job roles within the Medical Technology industry. Each course is mastery-based, self-paced, interactive, and takes 30-45 minutes to complete. An AdvaMed certificate is awarded at the completion of the track.

  • Corporate Compliance

     

    The Corporate Compliance Certificate is ideal for individuals in compliance, legal and/or sales management professionals. Topics include:

     

    • Basics of the AdvaMed Code
    • Introduction to Medical Device Compliance
    • HIPAA/Privacy Guidelines for Medical Device Sales Representatives

     

  • Medical Technology

     

    The Medical Technology Overview Certificate is ideal for industry generalists who may be new to the Medical Device industry or whose job role requires broad knowledge of several key areas. Topics include:

    • Global Regulatory Strategy and Planning Process
    • Introduction to Quality System Regulation (QSR)
    • Complaint Management
    • RA / QA

       

      The RA/QA Certificate is ideal for Regulatory Affairs and Quality professionals. Topics include:

      • Medical Device Filings: 510(k), PMA and IDE
      • Introduction to Quality System Regulation (QSR)
      • ISO 14155: Obligations of Sponsors & Monitors for Medical Device Trials

    Featured Course:

    Global Regulatory Strategy and Planning Process

    As your company develops a new or modified product, the impact of various regulatory requirements may shape how the company views marketing plans, launch activities, and product lifecycle management.

    A regulatory strategy and planning process creates one or more formal documents that are used to identify and align the regulatory submission activities with the development and business strategy for a new or modified product.

    After completing this course, you will know how to create a regulatory strategy and plan that can meet your company’s development needs while meeting regulatory submission requirements for a variety of regulatory environments.