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...
Different CDSCO Licensing Pathways for SaMD in India: A Guide
Software as a Medical Device (SaMDs) are now playing critical roles in patient care, diagnostics, and treatment decisions. Unlike general health apps, SaMD directly influences clinical outcomes, making oversight essential to ensure safety, efficacy, and reliability....
10 Common Pitfalls in CDSCO SaMD License Application
In India, Central Drugs Standard Control Organization (CDSCO) stringently regulates Software as a Medical Device (SaMD). Therefore, securing the CDSCO SaMD license is a mandatory requirement for marketing your product in India. Owing to its increased...
How to Implement an Effective CDSCO Medical Device QMS in 2026?
CDSCO medical device QMS is a strategic framework that ensures patient safety, operational discipline, and market access. Preparing one effectively means going beyond documentation. Manufacturers should treat the QMS as a living system. It should be continuously...