Based on Quigley M, Downey L, & Hatherall L., ‘Living in a Material World? Regulatory Challenges of Software as a Medical Device‘ (2026) Legal Studies: 1-20. This post was originally published on Birmingham Law School Research and Scholarship Blog and is cross-posted here. we discuss how the rise of software as a medical device challenges … Continue reading “The Unbearable Lightness of Being Intangible: Regulating Software as a Medical Device”
Tag: Software as a Medical Device
Software as a Medical Device: A Bad Regulatory Fit?
This post introduces some of the gaps and uncertainties we are exploring in relation to software as a medical device Advances in information technology have resulted in increasingly complex or “smart” medical devices that are capable of running software, lending these devices ever more complex functionalities. Often the relevant software comes as part and parcel … Continue reading “Software as a Medical Device: A Bad Regulatory Fit?”