Articles tagged with “21-cfr-820”

IEC 62304 vs FDA CSA: A Medical Software Compliance Guide

Compare the IEC 62304 standard vs. FDA CSA guidance for medical software. Learn key differences in scope, risk classification, validation, and documentation.

35 min read

12/28/2025

iec 62304 fda csa medical device software software validation 21 cfr 820 qms software regulatory compliance iso 13485