Automate Regulatory Research for FDA Submissions

Hardware Compliance's AI agents analyze your product specifications against thousands of pages of regulatory standards, including FCC, CE marking, FDA 510(k), UL, ISO, FAA, IEC, and more. The agents surface every applicable requirement with full citations and source text, replacing weeks of manual research with an automated workflow that produces results in minutes. The output is product-specific, not generic — every requirement is tied directly to your product's characteristics and target markets.

Traditional compliance consultants research regulations manually, charge by the hour, and take months to deliver documentation. Hardware Compliance's AI agents perform the same regulatory research across the same standards in a fraction of the time, then automatically generate technical files, test plans, and hazard analyses. Industry professionals still review and sign off on AI-generated documentation before submission, giving you AI speed with human accountability — without the consulting price tag.

Hardware Compliance covers a broad range of hardware compliance standards including FCC, CE marking, FDA 510(k), UL Certification, UL 3100, UL 3300, ISO 9001 and 9100, ISO 26262, FAA, IEC 62368-1, MIL-STD, ASTM, ANSI, and RIA. The platform is designed for hardware products across robotics, medical devices, drones, consumer electronics, automotive electronics, and aerospace and defense.

Hardware Compliance replaces months of manual regulatory research and compliance consulting with a workflow that takes weeks. The AI agents analyze your product specs and surface applicable requirements quickly, so your team can move into documentation and lab testing without the extended research phase that typically delays hardware compliance timelines.

Hardware Compliance supports multi-market compliance and maps requirements across US, EU, UK, and other jurisdictions at the same time. When you provide your product specifications and target markets, the AI agents research all applicable standards across every geography in a single workflow, so you receive a unified compliance picture rather than running separate research processes for each market.