Gain insight into SaMD today

The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory convergence.​Through the IMDRF, regulators reached consensus on what software is considered a medical device. Regulators call it ‘software as a medical device’ (SaMD). This paper provides an overview of:

  • The history of SaMD regulation
  • US/FDA regulation of SaMD 
  • EU regulation of SaMD
     

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