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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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