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.
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Articles tagged with “samd”
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.