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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
    FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: …

Training and Continuing Education | FDA

    https://www.fda.gov/training-and-continuing-education
    CDRH Learn Online courses for industry on safety and effectiveness of medical devices and exposure to radiation from medical devices. ORAU Free online courses for state, …

Medical Device Reporting & Complaint Handling Training …

    https://worldcomplianceseminars.com/p/medical-device-post-market-regulations-online
    Course Description- Medical Device Reporting Training. This course on Medical Device Complaint Handling Training aims at providing a close understanding of MDR & recall …

Medical Devices News and Events | FDA

    https://www.fda.gov/medical-devices/medical-devices-news-and-events
    FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes January 10, 2023 CDRH Statements - Statements from the Center for Devices and Radiological Health …

2022 Drug and Medical Device Seminar | DRI

    https://www.dri.org/education-cle/seminars/2022/dmd
    Live from Music City: New Releases from the Drug and Medical Device Committee! Join us in Nashville for the 2022 Drug and Medical Device Seminar! The seminar will provide countless opportunities to network …

2023 Drug and Medical Device Seminar | DRI

    https://www.dri.org/education-cle/seminars/2023/dmd
    Stay Current on New Developments in Drug and Medical Devices! Join us in historic New Orleans for the Drug and Medical Device industry’s premier event for learning, …

MDR Data Files | FDA

    https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files
    The FDA makes medical device reports available to patients and health care providers on the FDA's public Manufacturer and User Facility Device Experience …

Medical Device Material Safety Summaries | FDA

    https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-material-safety-summaries
    The reports focus on answering five key questions about local and systemic response to specific materials commonly used in medical devices. Medical Device …

eCFR :: 21 CFR Part 806 -- Medical Devices; Reports of …

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-806
    (a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly …

Trainings for medical devices - World Health Organization

    https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/management-use/trainings
    Priority medical devices list for the COVID-19 response and associated technical specifications Download Read More 26 June 2020 Biomedical equipment for …



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