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.

An overview of the IEC 62304 standard for medical device software. This guide explains its purpose, scope, and required life cycle processes for safety.

Learn the official definition of Software as a Medical Device (SaMD) from the IMDRF. Understand its scope as standalone software and its regulatory status.