6 Key EU MDR Requirements for SaMD & How to Comply?
EU Medical Device Regulation (EU MDR) has placed the Software as a Medical Device (SaMD) under a strict risk-based framework (EU MDR Rule 11). EU MDR broadened the scope for SaMD compared to the old Medical Device Directive (MDD). Many software products previously...
12 Essential Documents for CDSCO SaMD License Application
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...
How to Easily Register Software as a Medical Device in India?
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...
CDSCO Classification for SaMD in India: Your Guide
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...