Software as Medical Device

SaMD is software which, on its own, is a medical device. This can include software applications intended for treatment, diagnosis, mitigation and prevention of diseases. SaMD may be used in combination with, or interface with, other medical devices, as well as general purpose software.

SaMD requires specific documentation, submission and QMS adaptation, and IEC 62304 requirements must also be implemented. Our team of experts can help you with specific knowledge and experience on Software Devices.