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Medical devices: software applications (apps) - GOV.UK

    https://www.gov.uk/government/publications/medical-devices-software-applications-apps
    Medical devices regulation and safety Guidance Medical devices: software applications (apps) Information on when software applications are considered to be a …

Software and AI as a Medical Device Change Programme

    https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme
    Software and AI as a Medical Device Change Programme The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious …

Software and AI as a Medical Device Change …

    https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme/software-and-ai-as-a-medical-device-change-programme-roadmap
    In the UK, many of these products are regulated as medical devices. Last year, the MHRA announced the Software and AI as a Medical Device Change …

Transforming the regulation of software and artificial …

    https://www.gov.uk/government/news/transforming-the-regulation-of-software-and-artificial-intelligence-as-a-medical-device
    Transforming the regulation of software and artificial intelligence as a medical device The Medicines and Healthcare products Regulatory Agency (MHRA) is …

Chapter 10: Software as a Medical Device - GOV.UK

    https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom/chapter-10-software-as-a-medical-device

    MHRA Guidance on Medical Software and …

      https://www.regdesk.co/mhra-guidance-on-medical-software-and-applications/
      Mar 16, 2021. The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has published guidance dedicated to the medical device …

    Software as a Medical Device (SaMD) | FDA

      https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
      The term Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as " software intended to be used for one or more medical …

    MHRA Software flowchart - GOV.UK

      https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/548313/Software_flow_chart_Master.pdf
      This guidance document replaces the previous MHRA guidance titled “medical device standalone software, including apps”. As well as medical device apps becoming a …

    Medical devices and software applications - Health …

      https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/medical-devices-and-software-applications/
      MHRA’s guidance about software and apps; Is your app a medical device? It’s healthy to know: regulator issues updated guidance; MHRA guidance on the …

    MHRA Guidance on Stand-alone Software Medical Devices

      https://omcmedical.com/mhra-guidance-on-stand-alone-software-medical-devices/
      A software device is considered to have a medical purpose if it has one of the following features and looks into in vitro data: Concerning a physiological or …



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