Your Passport to Global Markets.
Execution is everything. Whether it's a Traditional 510(k), a De Novo, or an MDR Technical File, we write, compile, and submit your dossier to get you approved.
FDA 510(k)
Full service preparation: Administrative, eSTAR, Substantial Equivalence, and Performance Data summary.
CE MDR
Transition from MDD to MDR. We upgrade your Clinical Evaluation (CER), Risk Management, and PMS plans.
Reviewer Interaction
We handle the Q-Sub meetings and AI (Additional Information) requests. We speak 'Regulator' fluently.
Clear Path, No Detours.
First-Time Right
Our submissions have a 95% acceptance rate on first review because we pre-validate everything.
Rapid Response
When the FDA asks a question, the clock ticks. We draft responses within 48 hours.
Fixed Price
No hourly billing surprises. We quote a fixed price for the submission package.
Submission Lifecycle
Gap Assessment
Verify all testing and documents are ready.
Dossier Compilation
Writing the summaries, formatting the eSTAR/Technical File.
Submission & Defense
Submit to authority. Defend the file against questions until clearance.
Submission Packages
Frequently Asked Questions
How long does 510(k) take?
Typically 3-6 months for FDA review after submission.
Do you cover user fees?
No, FDA User Fees are paid directly by the manufacturer.
Can you help with Canada?
Yes, we handle Health Canada MDL applications as well.