How we work
Always know what comes next.
For a first 510(k), the hardest question is often “what now?” We map every step, from testing and documents to submission and FDA questions, give each one an owner and a date, and keep labs, translators and regulators moving on one plan.
- 1
Introductory call
Your device, target markets and distributors.
- 2
Written scope
Deliverables, timeline and fee, agreed before work starts.
- 3
Plan & submit
One project plan with owners and dates, and regular updates.
- 4
Review & lifecycle
Regulator questions, then support after approval.
Example timeline
US Class II device, 510(k)
Testing scope and duration depend on the device and the labs involved. Estimates only. FDA’s review clock pauses while it waits for answers to its questions, so total time depends on the device, testing readiness and response speed. International timelines depend on each country’s process; we map them during scoping.
Cost
Every project is quoted individually, after we review your device documentation and understand your needs. Regulatory authority fees (such as FDA user fees) and third-party testing are paid separately and are not included in our fee.
Can you guarantee clearance?
No consultant can guarantee a regulatory decision, and we do not. Regulators may raise questions on any submission. What we can do is reduce that risk and support you through to the final decision.
Find gaps first
We review your file the way a reviewer would, before it is submitted.
Ask early
Where appropriate, we confirm testing and strategy with FDA early through a Pre-Submission (Q-Sub).
Respond promptly
If the regulator raises questions, we prepare clear, complete responses with you.
Common questions
Do you work with distributors?
Yes. We align with your distributors on requirements, documents and timelines so everyone works from one plan.
Who does the work?
Experienced regulatory affairs professionals. Translation is handled in-house; we coordinate test labs and work directly with notified bodies.
Which markets are next for you?
Tell us about your device and where you want to sell it. We will give you an honest view of the pathway and a first step.