Hardware Certification Tool for FDA and CE Compliance

A hardware certification tool helps teams identify applicable regulatory standards, prepare required documentation, and navigate the testing process needed to bring a product to market legally. Hardware Compliance is an AI-powered platform that covers this workflow end to end — AI agents research every applicable standard for your product, auto-generate technical files and test plans, match you with the right accredited testing lab, and track certification progress from start to finish.

Hardware Compliance supports a broad range of standards including FCC, CE marking, FDA 510(k), UL Certification, UL 3100, UL 3300, IEC 62368-1, ISO 9001, ISO 9100, ISO 26262, FAA, ANSI, ASTM, MIL-STD, RIA, and more. The platform covers requirements across US, EU, UK, and other jurisdictions simultaneously, making it applicable to consumer electronics, medical devices, robotics, drones, automotive electronics, and aerospace hardware.

Traditional compliance consultants research requirements manually, bill by the hour, and scale with headcount — meaning slower turnaround and higher costs for complex multi-standard products. Hardware Compliance's AI agents read and reason across thousands of pages of regulatory standards and generate product-specific outputs automatically. The platform completes in weeks what typically takes months, at a fraction of traditional consulting costs, while expert review and sign-off ensures human accountability before lab submission.

Hardware Compliance replaces months of upfront compliance consulting with an AI-agent-driven workflow that takes weeks. The AI research and documentation phases — which traditionally consume the bulk of pre-testing time — are handled automatically. Actual lab testing timelines depend on the specific standards and labs involved, but Hardware Compliance ensures your team arrives at testing fully prepared, minimizing the risk of failed submissions and costly re-testing delays.

Hardware Compliance supports FDA 510(k) and CE marking requirements as part of its multi-standard coverage. The platform's AI agents surface every applicable FDA requirement with full citations, auto-generate required technical documentation, and connect medical device teams with accredited testing labs. Expert review and sign-off by industry professionals is also available before submission, providing the human accountability that high-stakes medical device certification requires.