Software as a medical device - A comparison of the EU’s approach with the US’s approach

Software as a Medical Device Whitepaper Front Cover

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

Submit the form below to claim your free copy of this BSI medical devices white paper today.