Welcome to the AdvaMed 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 Certificate Program offers three tracks and leverages UL's online courses, which include both FDA and AdvaMed-reviewed 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:

    MedTech Europe Code of Ethical Business Practice

    The EucoMed course has been updated to reflect the new MedTech Europe Code of Ethical Business Practice (the Code). Medical Device companies can use this course to train sales teams and third-party distributors on the MedTech Europe Code, which goes into effect on Januart 1, 2017.

    Topics in this course include: General Criteria for Events, Specific Event Guidelines, Grants and Charitable Donations, Arrangements with Consultants, and Research.

    After completing this course, learners will be able to recognize the guidelines that apply to the many types of interactions between MedTech Europe members (Members or MedTech Members) and healthcare professionals (HCPs) and/or healthcare organizations (HCOs).

    Learners can take the course on a PC or tablet.