Medical Device Software (disambiguation)

Medical Device Software may refer to:

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  Medical device software (general category)

  The general term for software that is used in or with medical devices to support medical purposes (e.g., diagnostic or treatment functions).

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  FDA medical device software guidance and regulations (USA)

  U.S. FDA regulatory framework and guidance documents that define and govern software as a medical device and related classification principles.

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  IMDRF software as a medical device framework

  The international IMDRF framework for how software as a medical device (SaMD) and related systems are classified and regulated across jurisdictions.

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  IEC 62304 (software lifecycle processes for medical device software)

  A widely used international standard specifying software lifecycle requirements for medical device software development.