Software is increasingly playing a central role in healthcare, from diagnostic algorithms to clinical decision support tools and patient monitoring applications. When such software performs a medical purpose without being part of a physical device, it is classified as Software as a Medical Device (SaMD). In India, SaMD is regulated under a defined legal and regulatory framework to ens... https://operonstrategist.com/services/regulatory-approvals/cdsco-registration-for-software-as-a-medical-device-samd-in-india/