Class: NP Source: MakroCare whitepaper Last export: Sept 30, 2024

Note - SaMD has certain exclusions, and SiMD is scoped to on-device software/firmware, so there is definitely an ‘OTHER’ category not discussed here.

** SaMD: Software as medical device**

• Software designed for medical purpose, operating independently of physical medical device hardware.
• Might be running on a phone, desktop computer, or it could be a cloud-based system
• Eg - Application which interprets images to detect cancer
• Eg - Software that analyzes patient data to recommend medication dose
• Eg - Health monitoring app which measures/tracks blood glucose levels and issues warnings.

** SiMD: Software in medical device**

• Software essential for operation of a hardware device, typically critical to performance / reliability.
• Eg - Firmware controlling infusion pump dose & timing.
• Eg - Ultrasound machine software processing and enhancing images for display
• Eg - Operating system for blood analysis device which manages tests & interprets data

Both SaMD and SiMD require a 09102405251 Software BOM (SBOM)