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Medical Device Reporting (MDR): How to Report Medical …

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
    Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form ...

Vigilance Reporting Requirements according to EU MDR 2017/745

    https://www.qualitymeddev.com/2021/02/25/vigilance-reporting/

    Vigilance Reporting Under the MDR: Insider's Guide

      https://www.linkedin.com/pulse/vigilance-reporting-under-mdr-insiders-guide-ethan-drower
      This article reviews vigilance system reporting requirements in the EU and gives tips on how you can ensure compliance and appropriate follow-up for any events …

    Do you know the requirements and your …

      https://www.bsigroup.com/meddev/LocalFiles/en-US/Whitepapers/bsi-md-whitepaper-vigilance.pdf
      Do you now the requirements and your responsibilities for medical device vigilance reporting Considerations To support compliance to the vigilance …

    EU MDR Vigilance Reporting and MEDDEV …

      https://www.orielstat.com/blog/eu-mdr-ivdr-vigilance-reporting-requirements/
      MEDDEV 2.12-1 Rev 8 was published in January 2013 and provides guidance to medical device manufacturers on market surveillance. It continues to be …

    Medical Device Reporting for Manufacturers | FDA

      https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-reporting-manufacturers
      FDA-2013-D-0743. Issued by: Center for Devices and Radiological Health. This guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) …

    EU Medical Device Vigilance Reporting in Europe - Emergo

      https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe
      Download our complimentary white paper, "Medical Device Vigilance Reporting in Europe," for an overview of event types that must be reported. In addition to MEDDEV 2.12/1, the …

    Market surveillance and vigilance - Public Health

      https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en
      The purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the …

    Incident reporting for medical devices: …

      https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html
      Submission of inadequate incident reports by reporters, for which Canada Vigilance - Medical Device Problem Reporting Program is consistently required to …



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