Hazard Analysis Software That Understands Your Product

Hardware Compliance uses AI to generate product-specific hazard analysis and risk assessment documents for FDA 510(k), UL, and ISO certifications.

Why Hazard Analysis Stalls Teams

Generic Tools Miss Critical Risks

Off-the-shelf solutions produce boilerplate outputs that don't reflect your product's actual safety profile or applicable standards.

Documentation Gaps Cause Resubmissions

Incomplete hazard analyses trigger lab rejections and resubmissions, costing months and significant budget before testing even begins.

Standards Are Dense and Fragmented

HARA requirements are buried across thousands of pages of ISO, UL, and FDA standards that take weeks to manually interpret.

AI Hazard Analysis Built for Your Certification

Hardware Compliance's AI agents read every applicable standard for your product, auto-generate product-specific hazard analysis and HARA documents, and connect you with the right accredited testing lab — all in weeks, not months.

Hazard Analysis Software Built for Hardware Compliance

Every feature is designed to take your product from risk assessment through certified documentation to lab-ready submission.

Product-Specific Hazard Analysis Generation

Risk Assessment

Product-Specific Hazard Analysis Generation

Hardware Compliance AI auto-generates HARA documents, risk matrices, and safety assessments aligned with your exact product type and applicable standards — not generic templates that miss product-specific risks.

  • HARA document generation
  • Product-specific risk matrices
  • Standards-aligned safety assessments
AI Research Across Safety Standards

Standards Research

AI Research Across Safety Standards

AI agents analyze your product specs against thousands of pages of ISO, UL, FDA, and IEC standards to surface every hazard analysis requirement with full citations — replacing weeks of manual research.

  • Covers ISO, UL, FDA, IEC
  • Full requirement citations
  • Minutes instead of weeks
Cited Sources for Every Requirement

Regulatory Traceability

Cited Sources for Every Requirement

Every hazard analysis requirement is traceable to the exact standard text, page number, and section. Auditors and testing labs see precisely where each HARA element originates.

  • Exact page and section citations
  • Full standard text visibility
  • Audit-ready traceability
Technical File Drafting for Lab Submission

Documentation

Technical File Drafting for Lab Submission

Beyond the HARA itself, Hardware Compliance auto-generates the complete technical documentation package testing labs require — so your submission arrives complete and ready for review.

  • Complete technical file packages
  • Lab-ready documentation
  • No assembly from scratch
Expert Review Before Lab Submission

Human Oversight

Expert Review Before Lab Submission

Industry professionals with backgrounds in UL, FDA, and ISO review and sign off on all AI-generated hazard analysis documentation before it reaches the lab, combining AI speed with human accountability.

  • Industry professional sign-off
  • Pre-submission review
  • AI speed with human accountability

Frequently Asked Questions

Get Your Hazard Analysis Done Right

Book a call to see how Hardware Compliance generates product-specific HARA documents and accelerates your path to certification.

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