About the course

Includes:   - SYS-036, Vigilance Reporting Procedure - Vigilance Reporting Webinar and Slides - FRM-048, Serious Incident Reporting Decision Tree - Manufacturer Incident Report for Serious Incidents - Manufacturer's Periodic Summary Report - Field Safety Corrective action Report Form - Urgent Field Safety Notice

Curriculum

1 Chapter · 8 Lessons

    1. (Included in full purchase)

      SYS-036: Vigilance Reporting Webinar

    2. (Included in full purchase)

      SYS-036: Vigilance Reporting (Slides)

    3. (Included in full purchase)

      SYS-036: Vigilance Reporting Procedure

    4. (Included in full purchase)

      FRM-048 Serious Incident Reporting Decision Tree

    5. (Included in full purchase)

      Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) Version 7.3.1

    6. (Included in full purchase)

      Manufacturer’s Periodic Summary Report (PSR) Medical Devices Vigilance System (MEDDEV 2.12/1 rev 7)

    7. (Included in full purchase)

      Field Safety Corrective Action Report Form Version 4, 2024

    8. (Included in full purchase)

      Urgent Field Safety Notice (2018)

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