About

FDA Guidance for Software Validation Kit for SaMD and SiMD

GrassrootsDX provides a DIY Software Regulatory Kit for medical device software teams seeking practical support with FDA guidance for software validation. The kit brings together design history file templates, on-demand training, and expert Q&A support to help teams document software requirements, testing, risk management, and traceability in line with IEC 62304. Teams developing SaMD or SiMD can use these resources to build a structured development process and prepare supporting documentation for regulatory submissions. Contact GrassrootsDX to learn more about the DIY Software Regulatory Kit and how it can support your software validation efforts.