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Software as a Medical Device (SaMD) is a software that is intended to be used for medical purposes and is not a part of any medical device hardware. SaMD includes both medical devices as well as in-vitro medical devices.

Classification of SaMD

As SaMD differs from traditional medical devices, it cannot be classified the same way as the medical devices. SaMD can be classified based on following two criteria:

  • Based on the type of information provided by the device
    • For treatment or diagnosis
    • For driving clinical management
    • For informing clinical management
  • Based on the impact on treatment
    • Critical
    • Serious
    • Non-serious

Clinical Evaluation of SaMD

Clinical evaluation of SaMD is conducted to generate, collect, analyze and assess the data related to the device to ensure its safety and efficacy. Following are the major components of the clinical evaluations performed on SaMD:

  • Valid Clinical Association – Verifies the association between the output of the SaMD and the target clinical condition
  • Analytical Validation – Demonstrates the technical relevance of the output of the SaMD
  • Clinical Validation – Demonstrates that reliable outcomes are generated from the SaMD after testing it on the target population

SaMD is the future of medical devices in the life sciences industry. With health authorities (such as FDA, EMA, Health Canada, TGA etc.) introducing regulations for SaMD, it is advisable for manufacturers to keep abreast of them. For more information, reach out to Freyr at sales@freyrsolutions.com.