Upload your FDA 510(k) or technical file. Our 3-stage AI engine identifies every gap for EU MDR, Japan PMDA, Health Canada, and 3+ more markets — in minutes. Files are permanently deleted 60 minutes after your report is generated.
The FDA uses AI to review your submission. ELSA 4.0 is now flagging gaps that human reviewers missed — causing unexpected delays and rejection letters. Companies that prepare for AI-powered review get approved faster.
Four steps from dossier to actionable gap report.
Upload your FDA 510(k), technical file, or any existing regulatory dossier as a PDF.
Choose the countries you want to enter: EU, Japan, Canada, Australia, UK, and more.
Our AI cross-references your submission against each market's exact regulatory requirements.
Receive a detailed, actionable PDF report with every gap ranked by severity and exact steps to fix them.
The FDA now uses AI internally to review submissions. Our engine mimics ELSA's review patterns so your dossier is ready.
Traditional regulatory consultants charge $50k+ and take 6 weeks. Get the same depth of analysis in under 10 minutes.
EU MDR, Japan PMDA, Health Canada, Australia TGA, UK CA Mark, Brazil ANVISA — all covered with real article references.
Every gap comes with a specific recommendation, the exact regulatory article, and estimated cost and timeline to resolve.
A comprehensive, submission-ready gap analysis with exact regulatory references.
{
"device": "Continuous Glucose Monitor (Class II)",
"overall_risk_level": "high",
"readiness_score": { "EU_MDR": 42, "Japan_PMDA": 31 },
"critical_gaps": [
{
"market": "EU MDR",
"title": "Clinical Evaluation Report (CER) required",
"reference": "EU MDR 2017/745 Annex XIV §1",
"severity": "critical",
"recommendation": "Conduct systematic literature review +
clinical investigation. Estimated 8-14 months, $120k-$180k."
},
{
"market": "Japan PMDA",
"title": "Japanese clinical data required for Class III",
"reference": "PFSB/ELD Notification No. 0331015",
"severity": "critical",
"recommendation": "Submit bridging study or conduct
local clinical trial with PMDA agreement."
}
]
}One price. Instant results. No annual contracts.
One dossier, any target market
Best for multi-market expansion
For regulatory teams & consultants
Traditional regulatory consultants charge $20,000–$50,000 for the same analysis. We charge $1,500 and deliver in minutes.
Every month your product is delayed in regulatory approval costs you market share. Start today.
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