Software as a Medical Device (SaMD), a type of digital health technology, is standalone software that can aid a clinician in making decisions, provide treatment options for a condition, or even provide early diagnosis of life-threatening diseases.
As SaMD is growing regulators are faced with the challenges of regulating software that can have frequent updates, potentially changing safety and/or effectiveness of the software. The ability to download software over the internet also poses risks as the traditional physical boundaries of containment are no more.
LTTS enables a robust culture of quality and organizational excellence, supporting in regulatory harmonization.
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