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...
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....
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...
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