AI Regulatory Compliance Research Done Right

Hardware Compliance covers a broad range of hardware standards including FCC, CE marking, FDA 510(k), UL Certification, ISO 9001/9100, ISO 26262, FAA, UL 3100, UL 3300, IEC 62368-1, MIL-STD, ASTM, ANSI, RIA, and more. The AI agents read and reason across thousands of pages of these standards to surface every requirement applicable to your specific product.

Traditional compliance consultants charge significant fees and take months to manually research applicable standards — and their throughput is limited by headcount. Hardware Compliance's AI agents perform the same regulatory research in a fraction of the time, surface every applicable requirement with full citations, and auto-generate the required documentation. Expert review is still built in where human sign-off matters most.

Hardware Compliance's AI regulatory research agent analyzes your medical device or hardware product specs against FDA 510(k) requirements and CE marking directives simultaneously. It surfaces every applicable requirement with exact source citations, then auto-generates the technical documentation packages those pathways require, reducing the risk of missed requirements that could delay clearance.

Hardware Compliance replaces what traditionally takes weeks of consultant research with AI-driven analysis that runs in minutes. The overall compliance journey — from regulatory research through documentation drafting and lab matching — is designed to take weeks rather than the months typical of traditional approaches. Timelines depend on your product type, target markets, and applicable standards.

Hardware Compliance supports multi-market compliance research across US, EU, UK, and other jurisdictions simultaneously. If your product targets both the US market under FCC and FDA rules and the EU market under CE marking requirements, Hardware Compliance maps all applicable requirements across both jurisdictions in a single workflow, so nothing falls through the cracks.