FDA clearance for your medical device, without big-firm overhead.
20 years in medical device regulatory affairs. 13 FDA 510(k) clearances across 8 review panels. You work directly with the senior consultant who does the work.
Contact
info@oconnellandmyers.com
Three ways to work with me
Pick the level of help you need. Every path starts with a free 30-minute call.
Regulatory strategy
We work out your device's classification and the best FDA pathway together, plus the predicate and testing plan, before you spend money on the wrong path.
Where every project starts
Done for you
I build and submit your 510(k) and handle FDA's questions through the review.
Best for: getting to market fastest
Guided drafting
Your team writes the submission while I walk you through each section. Then I review it the way an FDA reviewer would, before FDA ever sees it.
Best for: teams with in-house writers
20
Years in regulatory affairs13
FDA 510(k) clearances8
FDA review panels1
Senior expert on every projectWhy work with me
You work with me, not a junior
The person on your free call is the person doing the work.
A clear quote before we start
No open-ended hourly bills.
A roadmap you can show investors
Milestones and a realistic FDA timeline from day one.
A track record you can check
13 FDA 510(k) clearances across 8 review panels.
Areas of Expertise
How it works
Book a free call
30 minutes. Tell me about your device, where you are and when you need to be on the market.
Get a clear plan
You get your pathway, the gaps I see and a clear quote up front, before any work starts.
Get to FDA
We build your submission together, or I build it for you, and I stay with you through FDA review.
Let’s talk about your device.
Twenty years of regulatory experience, and the first conversation is free. Book a 30-minute consultation, send a short note through the contact form, or email info@oconnellandmyers.com.