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  1. www.who.int › health-topics › medical-devicesMedical devices - World Health Organization (WHO)

    5 de mar. de 2021 · Within the context of a robust health system they ensure access to safe, effective, and high-quality medical devices that prevent, diagnose, and treat disease and injury, and assist patients in their rehabilitation.

    • In Vitro Diagnostics

      Over 40 000 products are available today for in vitro...

    • Patient Safety

      Recognizing the huge burden of patient harm in health care,...

    • Hypertension

      Hypertension is a serious medical condition and can increase...

  2. www.gov.uk › guidance › medical-devices-information-for-users-and-patientsMedical devices: information for users and patients - GOV.UK

    11 de feb. de 2019 · A medical device is a healthcare product or piece of equipment that a person uses for a medical purpose. It is not a medicine or drug. Medical devices can diagnose, monitor or treat disease and...

  3. www.fda.gov › guidance-medical-device-patient-labelingGuidance on Medical Device Patient Labeling | FDA

    This guidance assists manufacturers in their development, and assist Center reviewers in their review and evaluation of medical device patient labeling.

  4. www.nejm.org › doi › fullAn FDA Viewpoint on Unique Considerations for Medical-Device...

    6 de abr. de 2017 · Medical devices range from something as simple as an elastic bandage to something as complicated as a deep-brain stimulator. This review describes the FDA approach for understanding and...

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  6. www.fda.gov › medical-devicesMedical Devices | FDA - U.S. Food and Drug Administration

    Approvals and clearances, information on medical devices by type. Digital Health Center of Excellence. Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as...

  7. www.fda.gov › files › about fdaFrequently Asked Questions About Medical Devices

    3. What are examples of medical devices? Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins.

  8. www.england.nhs.uk › long-read › medical-devices-and-digital-toolsNHS England » Medical devices and digital tools

    25 de may. de 2023 · Check if patient consent is required to use a medical device or digital health tool, and if so what form of consent is appropriate. Think ‘what are the risks, and have they been mitigated?’ Use medical devices and digital tools as intended and prescribed by manufacturers’ instructions.