Automate Compliance Documentation for FDA and CE

Hardware Compliance automates technical files, test plans, hazard analyses (HARA), risk assessments, compliance reports, and declarations of conformity. The AI agents generate these documents by analyzing your product specs against the applicable standards — whether that's FDA 510(k) technical files, CE marking documentation, FCC exhibits, or UL technical packages. Each output is product-specific, not a generic template, and is backed by full citations to the underlying regulatory text.

Traditional compliance consultants charge significant hourly or project fees and operate at human research speed, often taking months to produce documentation. Hardware Compliance's AI agents read and reason across the same regulatory standards in a fraction of the time, automating the documentation drafting that would otherwise consume consultant hours. Industry professionals still review outputs before lab submission, so you get AI throughput with human accountability rather than choosing between speed and rigor.

Hardware Compliance supports documentation automation across FCC, CE Marking, FDA 510(k), UL Certification, ISO 9001 and 9100, ISO 26262, FAA, UL 3100, UL 3300, IEC 62368-1, MIL-STD, ASTM, ANSI, RIA, and more. The platform covers US, EU, UK, and other jurisdictions simultaneously, so teams targeting multiple markets can automate compliance documentation for every applicable standard in a single workflow.

Hardware Compliance is designed to replace a process that traditionally takes months with a workflow that takes weeks. The AI agents begin surfacing applicable requirements and generating draft documentation as soon as product specs are provided. Exact timelines depend on the complexity of your product and the number of standards involved, but the platform is built specifically to compress the research and documentation phases that consume most of the compliance calendar.

Hardware Compliance's AI agents are built to read and reason across regulatory standards rather than apply static templates, which means outputs are product-specific and citation-backed. Every AI-generated documentation package goes through expert review and sign-off by industry professionals before it reaches a testing lab or regulatory body. This combination of AI-driven automation and human review is designed to produce documentation that meets the accuracy standards required for real certification submissions.