Does software belong in the Technical File?

Yes, software belongs in the Technical File if it controls, impacts, or is integrated into the consumer product.

As consumer products become more connected, regulatory authorities increasingly view software as an essential part of a product’s safety and functionality.

When Software Must Be Included:

Embedded Firmware: Software that directly controls the hardware, like operating a smart toaster or a battery management system.
Companion Apps: Mobile apps or software interfaces that control the product or process user data.
Connected Devices (IoT): Any smart consumer product featuring internet, Wi-Fi, or Bluetooth connectivity.

What Software Information Goes Inside:

Software Version: The exact release and version number of the software being deployed.
Architecture & Block Diagrams: High-level overviews detailing how the software operates and interacts with the hardware.
Cybersecurity Measures: Evidence showing protection against unauthorized access or remote hacking.
Validation Test Reports: Proof confirming that the software functions safely and will not cause physical malfunctions.
Software Bill of Materials (SBOM): An active inventory of any third-party or open-source software modules utilized.

Regional Context

European Union (EU): Under frameworks like the General Product Safety Regulation (GPSR) and the Cyber Resilience Act (CRA), standalone and embedded software are explicitly treated as products. Documenting digital elements is a strict legal requirement.
United States & Canada: While general consumer safety focus remains on physical hazards, if software updates or glitches can cause a physical risk (such as overheating lithium batteries or unexpected mechanical movement), the underlying software controls and their risk assessments must be included in your compliance file