iCertifi Alternative for Serious Hardware Compliance

Hardware Compliance goes further than static compliance databases by using AI agents that actively read and reason across FDA regulatory standards, then auto-generate the technical documentation your team needs for a 510(k) submission. Rather than pointing you to requirements and leaving documentation to you, Hardware Compliance drafts your technical files and test plans, and connects you with an accredited testing lab suited to your specific device type.

Hardware Compliance supports FCC, CE marking, FDA 510(k), UL Certifications including UL 3100 and UL 3300, ISO 9001 and 9100, ISO 26262, FAA, IEC 62368-1, MIL-STD, ASTM, ANSI, RIA, and more. Multi-standard and multi-market coverage means one platform handles your entire certification scope across the US, EU, UK, and other jurisdictions simultaneously.

Hardware Compliance replaces a compliance process that traditionally takes months with an AI-agent-driven workflow that takes weeks. The platform handles the research, documentation drafting, and lab matching phases that typically consume the most calendar time, so your team spends less time waiting and more time moving toward certification.

Hardware Compliance replaces the research and documentation phases that consultants typically bill the most hours for. AI agents surface requirements and generate technical files in a fraction of the time. The platform also includes expert review and sign-off by industry professionals, so documentation is validated before it reaches a testing lab. You retain human accountability without paying traditional consulting rates.

Hardware Compliance is well suited for medical device companies navigating FDA 510(k) and CE marking requirements. The platform's AI agents analyze your device specifications against applicable standards, generate the technical documentation packages regulators and notified bodies expect, and match your product with accredited testing labs experienced in medical device certification. Expert review is included before any documentation is submitted.