Areas of Expertise
Regulatory Strategy
The right FDA pathway, set early, so you don't pay to redo work later.
labeling development & review
Labels, IFUs and marketing claims that are accurate and backed by data.
U.S. Agent & Official Correspondent
Your required U.S. contact with FDA if you manufacture outside the United States.
FDA Submissions
510(k) submissions built in eSTAR and ready for FDA review.
Device listing
Devices listed with FDA correctly, and kept current as your products change.
supplier assessment
A supplier control program your team can run with confidence.
Establishment Registration
Registration, annual renewal and FDA fees handled on time, every year.
Design changes & Sustainability
Know when a device or supplier change needs a new submission, and when it doesn't.
UDI / GUDID
UDI labels and GUDID records set up right the first time.
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.