When is software a medical device? understanding and determining the “intention” and requirements for software as a medical device in european union law

HIGHLIGHTS

• who: Kaspar LUDVIGSEN and collaborators from the https://doiorg/101017/err.2021., Published online by Cambridge University have published the paper: When Is Software a Medical Device? Understanding and Determining the ``Intention'' and Requirements for Software as a Medical Device in European Union Law, in the Journal: (JOURNAL) of 11/03/2020
• what: For this paper, the market surveillance activities done by the regulators seen in Article 93 are central as well. The authors focus on aspects that are relevant for the analysis from this as well. The framework Firstly, the authors propose the following . . .
  

   

  

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