Software-as-a-Medical Device

Personalized devices with cloud based software

As per the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device (SaMD) is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware device”.

The use of SaMD in advancing public health continues to transcend limitations with a plethora of personalized hi-tech devices, AI and the advent of 5G. Wearable devices are expected to drive the way we capture, monitor, diagnose and respond to information as it becomes available. Even simple transcription software that once increased the efficiency of doctors, will look obsolete. This is because voice activated AI systems will capture our interactions with physicians and provide inferences, diagnoses and treatment plans while simultaneously sending out clinical orders and prescriptions by fax or email.

SigmaCan has several years of experience in software development, big data analytics, system integration, medical devices, product development and project funding. Together with its partners and regulators, SigmaCan can facilitate the SaMD life cycle processes and help maneuver and align with the regulatory framework for clinical evaluation, and compliance with the quality management system.

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