Software as a Medical Device (SaMDs) are now playing critical roles in patient care, diagnostics, and treatment decisions. Unlike general health apps, SaMD directly influences clinical outcomes, making oversight essential to ensure safety, efficacy, and reliability....
In India, Central Drugs Standard Control Organization (CDSCO) stringently regulates Software as a Medical Device (SaMD). Therefore, securing the CDSCO SaMD license is a mandatory requirement for marketing your product in India. Owing to its increased...
Software as a Medical Devices are regulated in India by the CDSCO. Hence, you need to mandatorily obtain the CDSCO SaMD license to market your product in India. To obtain a CDSCO license for Software as a Medical Device (SaMD), applicants must prepare a structured set...
Technology has revolutionized the healthcare industry. Currently, medical devices are not limited to physical devices. Recently, software is being used to monitor, diagnose, prevent, and even treat diseases. New-age technologies, which include software as a medical...
Currently, software is being used a medical device in the healthcare sector. These Software as a Medical Device (SaMDs) are used to diagnose diseases as well as decide the course of treatment. Hence, it is crucial to verify that the software performs as...