CDSCO License for Manufacturing Glucometer in India: A Guide
A glucometer is used to measure glucose levels and help manage conditions, like diabetes. Glucometer readings directly impact patient therapy and outcome. An incorrect reading poses a threat to patient safety. Hence, glucometers are strictly regulated by CDSCO in...
US FDA SaMD Classification System: A Comprehensive Guide
The US FDA classifies Software as a Medical Device (SaMD) using a risk-based framework. It places software into four classes (I–IV). Class IV represents the highest risk (life-critical decisions). On the other hand, Class I represents the lowest (supportive,...
Easily Navigating US FDA SaMD Registration Process
FDA requires SaMD registration to ensure that standalone medical-purpose software is safe, effective, and legally marketable in the United States. Registration is not just a formality. It establishes credibility, aligns product claims with regulatory expectations, and...
CE Mark Process for SaMD: Your Comprehensive Guide
European Union Medical Device Regulation (EU MDR) broadened the scope for SaMD compared to the old Medical Device Directive (MDD). Many software products previously considered low risk are now moderate or high risk under MDR. Moreover, as per EU MDR, SaMD is treated...