UK MHRA Published Guidance on Software as a Medical Device

Brain Nervous System Medical Device
UK’s MHRA announced the Software and AI as a Medical Device Change Programme last year to ensure regulatory requirements for software and AI are clear and patients are protected.
MHRA thinks that an inappropriate intended purpose statement can lead to non-compliance with the law and possible safety concerns and considering the emerging need of regulatory compliance in this area MHRA published the guidance on Software as a Medical Device.
MHRA is trying to outline some common concerns with…
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