# Medical devices

> Device software with a change record your auditors can follow.

Source: https://neuralinverse.com/industries/medical/

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[Industries / Mobility and devices](https://neuralinverse.com/industries/)

# Device software with a change record your auditors can follow.

For firmware and software teams under IEC 62304. Agents never read patient data, and controlled items wait for a named approver.

Standards

IEC 62304 · ISO 14971

Firmware tools

Arm GCC, Arm Compiler 6, IAR, J-Link, ST-LINK

Agent policy

Medical sector template

Models

Approved by your organisation, or self-hosted

Deployment

Self-hosted, your cloud or air-gapped

What your team gets

## Your quality system, with AI inside its rules.

Govern features are in use today. Domain modules are pre-release; their state is listed under Tools and formats.

- **Patient data kept from agents:** The medical template denies agent reads of DICOM files, patient exports and protected health information, and lists network destinations explicitly.
- **Controlled items:** Agent changes to requirements and risk management files, and pushes to main and release branches, wait for a named approver.
- **SOUP review:** A new third-party package needs an approver before an agent installs it.
- **Electronic signature records:** Approvals are signed records with the signer's name, time, meaning and reason, made after re-authentication and verified in CI.
- **Design history evidence:** Signed evidence packs and audit exports, verifiable offline, for your design history file.
- **Firmware in the Editor:** Build, unit-test, flash and debug device firmware with your compilers and probes.

Who uses it

## For the engineers who change the device and the people who release it.

- **Firmware engineers:** Build, flash and debug device software, with agents working under the medical template.
- **Verification engineers:** Run host unit tests, and firmware in an emulator in CI, with results per test.
- **Quality and regulatory:** Approve controlled items and export evidence for the design history file.
- **Risk management:** Review every agent change to risk management files as a named approver.

Tools and formats

## What the Embedded module handles, and how far it is verified.

The module drives the compilers and probes your team already uses. It turns on by itself in a trusted workspace with a firmware project.

- **Firmware projects:** Keil, IAR and STM32CubeIDE projects imported into CMake; builds of a CMake preset with a Flash and RAM report; host unit tests. Built and tested on recorded tool output; not yet run against IAR or Keil.
- **Flash and debug:** Flashing after a confirmation; debugging with peripheral registers from the SVD, RTOS awareness, fault decoding and a serial monitor. Running an image in QEMU is verified against QEMU 9.1.1; nothing has been run on a board.
- **Static analysis:** Cppcheck findings, including MISRA C:2012, in the Problems view. Built and tested on recorded tool output.

Domain modules are pre-release. Nothing is verified by a customer yet, and nothing is verified on Windows. Do not rely on a capability for production work until it is verified for your tools, versions and operating system. Product names belong to their owners.

How a change moves

## A person decides before anything leaves the desk.

1.  Propose
    
    An engineer or agent drafts a change to device software.
    
2.  Verify
    
    Your qualified tools build, check and test it.
    
3.  Approve
    
    A push to main or a release branch waits for a named approver.
    
4.  Record
    
    Change, results and approval kept together in the audit record.
    

Standards

## Evidence for your quality system. The clearance is yours.

- **IEC 62304:** Evidence toward IEC 62304: changes to requirements and released software with their approver, and SOUP additions reviewed before install.
- **ISO 14971:** Evidence toward ISO 14971: every agent change to risk management files reviewed by a named approver.
- **Electronic records:** Signature records support your own controls for electronic records and signatures. Identity verification at enrolment stays your process.

Neural Inverse provides evidence toward these standards. Certification stays with your organisation and assessor.

Products used

[Neural Inverse Build →

Editor, Agents and CLI with the domain tools your engineers need.](https://neuralinverse.com/build/)[Neural Inverse Govern →

Policy, approvals and audit for every AI tool your teams use.](https://neuralinverse.com/govern/)

Product names belong to their owners.

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## Talk to our team.

Neural Inverse is available by request. We work with your engineering, security and procurement teams from the first conversation.

[Request access](https://neuralinverse.com/contact/?topic=access)[Contact us](https://neuralinverse.com/contact/)