How to Get CDSCO License for SaMD Products? A Guide
Currently, medical devices are not just limited to physical devices. A software itself can be used as a medical device. Software as a Medical Device (SaMDs) are used not only to diagnose diseases but also to decide the course of treatment. Thus, it is important...
Clinical Validation of SaMD: Vital for Clinical Relevance
Software as a Medical Device (SaMD) is a software intended to be used for medical purposes without being part of a physical medical device. It can perform functions, such as diagnosing, preventing, monitoring, or treating diseases, by analyzing data and providing...
Quality Management System for SaMD: Focus Areas & Principles
Software as a Medical Device (SaMD) refers to a software that is intended to be used for medical purposes. SaMDs are not part of a physical medical device. The software itself is regulated as a medical device, even though it runs independently on computers,...