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...
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....