AI Regulatory & Legal Frameworks for Biopharma in 2025
Examines the 2025 AI regulatory frameworks for biopharma in the U.S., EU, U.K., and Canada. Details compliance obligations for GenAI, GxP, and SaMD.
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Articles tagged with “samd”
IEC 62304: Medical Device Software Life Cycle Processes
An overview of the IEC 62304 standard for medical device software. This guide explains its purpose, scope, and required life cycle processes for safety.
An Introduction to Software as a Medical Device (SaMD)
Learn the official definition of Software as a Medical Device (SaMD) from the IMDRF. Understand its scope as standalone software and its regulatory status.