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How to Determine if Your Product is a Medical Device | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
    Is your product a Device Software Function?The FDA refers to software functions that are device functions as “device softw…What to do if your product is not a medical deviceIf your product does not meet the definition of a medical device, it may … See more

Medical devices - World Health Organization

    https://www.who.int/health-topics/medical-devices
    A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related …

Medical device | definition of medical device by Medical …

    https://medical-dictionary.thefreedictionary.com/medical+device
    medical device. Any article or health care product intended for use in the diagnosis of disease or other condition or for use in the care, treatment, or prevention of disease that …

What are Medical Devices? - News-Medical.net

    https://www.news-medical.net/health/What-are-Medical-Devices.aspx
    A medical device is considered any apparatus that does not exert its action through chemical means and is used in diagnosis, mitigation, therapy, or prevention of …

Is My Product a Medical Device? - Food and Drug …

    https://www.fda.gov/media/131268/download
    Definition of a Medical Device (Continued) – recognized in the . official National Formulary, or the . United States Pharmacopoeia, or any supplement to them, – …

Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate …

What is a Medical Device? (Official definition for EU, …

    https://easymedicaldevice.com/medical-device-definition/
    Medical Device definition from the Medical Device Regulation MDR 2017/745 The full EU MDR Medical Device definition is: ‘medical device’ means any instrument, apparatus, appliance, software, implant, …

MDR - Article 2 - Definitions - Medical Device Regulation

    https://www.medical-device-regulation.eu/2019/07/10/mdr-article-2-definitions/
    Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, …

What is a medical device according to the MDR

    https://medicaldevicehq.com/articles/what-is-a-medical-device-according-to-the-mdr/
    The simplest way of describing what a medical device is would be to say that medical devices are things found in hospitals for treatment that are not medicines. Still, it …

Factsheet: medical devices overview - GOV.UK

    https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
    A medical device is any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by human beings for a medical...



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