Where We Serve

US Clients

Medical Device Companies Across the United States

Our primary client base is US-based medical device companies — startups, growth-stage companies, and established manufacturers — navigating FDA regulatory requirements. FDA regulatory work is conducted remotely and through FDA's electronic submission systems, which means geography is not a barrier to service quality. We have worked with clients in California, Massachusetts, Minnesota, Texas, Florida, Ohio, and across the country, delivering the same level of senior engagement regardless of location.

For clients requiring on-site work — facility gap assessments, mock FDA inspections, site initiation visits for clinical programs, or GMP certification preparation — we travel to client sites as part of the engagement. Our travel program covers the full continental United States, and we plan on-site visits efficiently to deliver maximum value per on-site day.

Weston, Florida Headquarters

ADB's headquarters sits in Weston, Florida, within a concentration of medical device manufacturers, distributors, and startups in the Southeast — particularly in orthopedics, cardiovascular, and digital health. That regional presence informs ADB's device-area experience; it is not a limit on who ADB serves, and in-person work is available by arrangement wherever an engagement calls for it.

Manufacturers Outside the United States: US Agent and Market Access

For medical device manufacturers outside the United States seeking US market access, ADB Consulting serves as FDA US Agent under 21 CFR 807.40. Our US Agent program provides more than registration management — it provides active regulatory representation with the expertise to navigate 510(k) submissions, import detentions, FDA correspondence, and the ongoing registration requirements that keep a non-U.S. manufacturer in good standing with FDA. Full detail on this program lives on the International Sponsor Program hub.

We work with manufacturers from any country, including common patterns we see from Europe, Latin America, Asia-Pacific, and the Middle East — navigating challenges such as import alert exposure, translation and labeling compliance, and the strategic question of whether to pursue US clearance independently or through a US-based distribution partner. Our US Agent program is designed to be a genuine regulatory partnership — not just a compliance address.

For companies with existing CE marks under EU MDR seeking FDA market access as a second regulatory jurisdiction, we provide pathway strategy that accounts for the differences in evidence requirements between the two frameworks and develops a data collection program that serves both submissions efficiently.

Service Summary

• United States: All FDA regulatory services, remote engagement, travel available for on-site work
• Manufacturers outside the United States: US Agent designation, FDA registration, 510(k)/PMA liaison, import detention response
• EU MDR companies: US market access strategy, dual-jurisdiction submission planning
• Latin America: ANVISA regulatory strategy support in the context of MDSAP programs
• Asia-Pacific: Japan PMDA and Australia TGA context within MDSAP multi-market programs

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