Regulatory and Compliance Documents

Flux is an AI hardware engineer. Prepare product documents from your project data so you can go to the test lab prepared.

Create a Technical Construction File

Tell Flux what product you are preparing and which markets it will enter.

This board has a Wi-Fi module and runs from USB. Which compliance documents do I need for the US and Europe? Write them.
Prepare a Technical Construction File for this wireless sensor for the US and EU.
Create the compliance checklist and draft Declaration of Conformity for this wireless product.

Flux can prepare a Technical Construction File for a wireless product. The project documents can cover US FCC radio certification, digital emissions and RF exposure, plus EU RED and RoHS. They can include an FCC filing package, an EU Declaration of Conformity, a compliance checklist, a wireless-module table from the BOM, a block diagram, RF evidence, a safety assessment, and a test plan.

Prepare a safety analysis

Tell Flux about the power source and product enclosure.

Prepare a safety analysis for this mains-powered smart plug and its enclosure.
Create a safety analysis for this AC/DC power supply and its mechanical housing.
Prepare safety documents for this battery charger, board, and enclosure.

Flux can write a safety analysis for mains-powered products, AC/DC equipment, and battery chargers.

Create a Design History File

Tell Flux which medical device and project records to document.

Create a Design History File for this medical wearable.
Organize the project design records for this wearable medical device.
Prepare the design documents for this medical sensor and its enclosure.

Flux can write a Design History File for a medical device.

Prepare automotive traceability

Tell Flux which automotive system and interfaces to document.

Prepare automotive traceability documents for this CAN node.
Create an ISO 26262 traceability document for this ECU project.
Document the CAN interfaces and project records for this automotive controller.

Flux can prepare automotive traceability documents for ECU and CAN projects.

Generate an FMEA report

See FMEA Report Generation for prompts and steps to generate an FMEA report.

Flux writes regulatory and compliance documents as project documents.