How to Import IVDs for Sale in India? Your Detailed Guide
In vitro diagnostic devices (IVDs) have diverse applications in the healthcare industry. India is still heavily import dependant for fulfilling its IVD needs. Hence, India imports large quantities of IVDs. Thus, Central Drugs Standard Control Organisation (CDSCO) has...
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,...