Course Outline

    1. Welcome!

    2. Pre-Course Survey

    1. UDIClearinghouse

    2. Module: IFUVitals

    3. Adverse Event & Reporting (Optional)

    4. Recalls (Optional)

    5. Device/Bio Hub (Optional)

    6. Help

    1. Seamless Access and Navigation

    1. LGG! Let's Get Going! Accessing UDIClearinghouse

    2. IFUVitals

    3. Device/Bio Management Hub (Optional)

    4. Recalls (Optional)

    5. Adverse Events and Adverse Event Reporting (Optional)

    6. Help

    1. Importance of Accessing Manufacturer Documents

    2. FDA Perspective on Manufacturer Labeling

    3. How Manufacturer Documents are Accessed and Utilized

    1. Device Identification Using UDI-DI

    2. Centralized Access to All Manufacturer and Facility Documents

    3. Importance of Following Manufacturer's IFU

    4. Compliance with ISO 13485 and FDA Quality Systems Regulation

    5. Joint Commission Standards on Reprocessing

    6. Reporting Device Failures

    7. Ensuring Comprehensive Care and Safety

    8. Recall and Safety Notification Safety Feature

Mastering UDIClearinghouse IFUVitals

  • Manufacturer Documents... IFUs | Manuals | PM Schedules