CertifyEvery layer. Every market.
Certified.
We take your product apart — material by material, component by component — and rebuild it as documentation that clears regulatory gates in 47 countries.
Compliance complexity doesn't announce itself.
It accumulates — until a container is stuck in port.
Average delay when entering EU market without pre-clearance documentation
Typical cost of a failed medical device audit before first submission
Regulatory frameworks a single IoT device must navigate to sell globally
Of first-time submissions rejected due to documentation gaps, not product failures
Five phases. Zero surprises.
Every one of them runs on our dashboard, visible to your team.
Gap Analysis
Know exactly what you're missing before it costs you.
We disassemble your product documentation — BOM, schematics, material declarations — against the regulatory requirements of every target market. Every gap is mapped to a specific standard, a specific test, a specific deadline.
- —RoHS substance declarations missing for 6 components
- —No EMC pre-scan data for EU Radio Equipment Directive
- —Battery UN38.3 report from wrong test lab (not accredited)
- —Labeling requirements for Japan unreviewed
Testing Coordination
The right lab. The right protocol. First time.
We coordinate with accredited test laboratories across 12 countries, preparing test plans that satisfy multiple certification bodies simultaneously. One test cycle covers EU, US, and UK where protocols overlap.
- —Submitted to wrong Notified Body for medical device class
- —Separate test runs for CE and FCC (60% overlap in protocols)
- —Lab queue time: 8 weeks without expedite relationship
- —Test failure on EMC — discovered 6 weeks before shelf date
Documentation Assembly
Technical files that pass on first review.
We build the complete technical file — Declaration of Conformity, technical construction file, test reports, risk assessments — formatted to the specific requirements of each authority. Every document cross-referenced, version-controlled, audit-ready.
- —DoC template downloaded from non-official source
- —Technical file missing risk assessment per ISO 14971
- —Version mismatch between test report and product spec
- —Supplier declarations expired — 4 need re-signing
Submission & Liaison
Direct lines to the authorities that matter.
We submit on your behalf and maintain direct communication with regulatory bodies, Notified Bodies, and test laboratories. When an authority raises a query, we respond within 24 hours with the precise technical answer they need.
- —FDA query response took 3 weeks (missed 30-day window)
- —Notified Body requested clarification — internal team unsure how to respond
- —CE self-declaration challenged — no technical file to support
Clearance & Monitoring
Cleared today. Protected tomorrow.
Once cleared, we monitor regulatory updates across all your active markets — standard revisions, transition deadlines, post-market surveillance requirements. Your certifications stay current without internal overhead.
- —EN 62368-1 transition deadline missed — product pulled from EU shelf
- —No post-market surveillance process for MDR compliance
- —China GB standard updated — distributor flagged violation
The numbers behind every cleared shipment.
"Our container was sitting in Rotterdam for 11 days. Certify identified the missing RoHS substance declaration within 4 hours and had the corrected documentation to customs within 48 hours."
"We were 6 weeks from EU shelf date with zero CE documentation. The Certify team ran parallel testing coordination and documentation assembly simultaneously. We shipped on time."
"A failed FDA audit was going to cost us $220K minimum before we'd even get a re-submission date. Certify rebuilt our 510(k) technical file in 18 days. Second submission cleared."
Tell us about your product.
We'll map every gate it needs to clear.
Within 48 hours of submission, you'll receive a preliminary compliance roadmap showing required certifications, estimated timelines, and critical path dependencies — at no charge.
Market Entry Compliance Checklist
47-point checklist covering documentation requirements, test lab accreditation, and submission timelines for EU, US, UK, China, and Japan. Used by 1,200+ product teams.