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Achieving SaMD Certification: A Comprehensive Guide to Compliance and Standards | #samd Regulation #samd Certification #samd #samd Classification

Achieving SaMD Certification: A Comprehensive Guide to Compliance and Standards

Achieving SaMD Certification: A Comprehensive Guide to Compliance and Standards

Obtaining SaMD certification involves understanding and fulfilling regulatory requirements, which include risk management, clinical evaluation, software validation, and thorough documentation.