Test Plan Generation Software for FDA and CE Compliance
Hardware Compliance's AI agents generate product-specific test plans aligned with FDA 510(k), CE, UL, and other standards — so your hardware passes certification on the first attempt.
Generic Tools Fail Compliance Teams
Plans Rejected at the Lab
Generic test plan templates miss standard-specific requirements, forcing costly rewrites and pushing your certification timeline back by months.
Standards Too Dense to Parse
FDA 510(k), IEC 62368-1, and UL standards span thousands of pages — manually extracting the right test requirements is slow and error-prone.
Failed Tests Delay Your Launch
A single gap in your test plan can mean a failed submission, expensive retesting fees, and weeks or months of lost market time.
Hardware Compliance Generates Compliant Test Plans Automatically
Provide your product specs and target markets. Hardware Compliance's AI agents read the applicable standards, extract every relevant test requirement with full citations, and auto-generate a product-specific test plan your lab can act on immediately.
Test Plan Generation Built for Hardware Compliance
From regulatory research to lab-ready test plans, Hardware Compliance automates the most time-consuming steps in your certification workflow.
Test Plans
Auto-Generate Product-Specific Test Plans
Hardware Compliance creates test plans directly aligned with the standards your product must meet — FDA 510(k), CE, UL, IEC, and more. Labs receive exactly what they need, formatted correctly, with no gaps or missing requirements.
- Standard-aligned test plans
- No manual formatting required
- Lab-ready on first draft
AI Research
Surface Every Applicable Test Requirement
Hardware Compliance's AI agents analyze your product specs against thousands of pages of regulatory standards to identify every test requirement that applies to your specific product — in minutes, not weeks.
- Full regulatory citations
- Product-specific analysis
- Covers FCC CE UL FDA and more
Traceability
Trace Every Requirement to Its Source
Every test requirement in your plan links back to the exact standard text, page number, and section. Full traceability gives your team and the lab confidence that nothing has been missed or misinterpreted.
- Exact standard page and section
- Full requirement traceability
- Audit-ready documentation
Documentation
Draft the Full Technical Documentation Package
Beyond the test plan, Hardware Compliance auto-generates the complete technical file package labs and notified bodies require — compliance reports, declarations of conformity, and supporting documentation — all aligned with your test plan.
- Complete technical files
- Declaration of conformity
- Consistent with test plan
Human Oversight
Expert Review Before Lab Submission
Industry professionals review your AI-generated test plans and documentation before they go to the lab. For high-stakes certifications like FDA 510(k) or ISO 26262, human sign-off ensures nothing gets missed.
- Professional review and sign-off
- Catches edge-case gaps
- AI speed with human accountability
Frequently Asked Questions
Get Your Test Plan Generated Today
Book a call with our team to see how Hardware Compliance generates compliant, product-specific test plans and accelerates your path to certification.
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