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Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation, and...

Medical Devices; Current Good Manufacturing Practice …

    https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation
    ----- SUMMARY: The Food and Drug Administration (FDA) is revising the current good manufacturing practice (CGMP) requirements for medical devices and incorporating …

Medical Device Manufacturers | FDA

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/medical-device-manufacturers
    Medical Device Manufacturers December 1997 4 GUIDE TO INSPECTIONS …

Overview of Device Regulation | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
    Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers, contract sterilizers, …

Quality System (QS) Regulation/Medical Device Good …

    https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

    Quality and Compliance (Medical Devices) | FDA

      https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices
      The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in …

    Medical Device Databases | FDA

      https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
      Apr 6, 2022

    Voluntary Medical Device Manufacturing and Product …

      https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program
      Voluntary Medical Device Manufacturing and Product Quality Pilot Program | FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program On …

    Recent Final Medical Device Guidance Documents | FDA

      https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents
      Recent Final Medical Device Guidance Documents | FDA Recent Final …

    FDA’s Approach to Medical Device Servicing

      https://www.fdanews.com/ext/resources/files/Conference2/MDQC19Presentations/Josephson-Servicing-Remanufacturing.pdf
      Medical devices are manufactured by manufacturers, sometimes also called original equipment manufacturers or OEMs Medical device manufacturers are required …



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