Software as a Medical Device

Digital health is a rapidly growing market driven by a need for more efficient and cost-effective healthcare, increasingly pushed towards remote monitoring and out of hospital care with the promise of better outcomes through personalized medicine.

Software as a Medical Device (SaMD) is the regulated sub-segment of digital health solutions, including digital therapeutics (DTx).

Industry demands are accelerating convergence of digital health technologies, combining patientcentric applications with telehealth and HCP dedicated apps as part of a holistic healthcare ecosystem, but also increasing complexity.

Accelerating technological change has created new ways for providers to engage with patients, creating a need to deliver SaMD solutions quickly to maintain market relevance thereby challenging the traditional business models.

Software as a Medical Device

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