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.

Southeast US: Florida and the Medical Device Corridor

Our Sunrise, Florida headquarters places us in the heart of Florida's growing medical device and life sciences ecosystem. Florida is home to a significant concentration of medical device manufacturers, distributors, and startups — particularly in the orthopedics, cardiovascular, and digital health categories. Companies in South Florida, the Tampa Bay region, and Orlando benefit from the option of in-person engagement without travel cost, while still accessing the full range of regulatory services we offer nationally.

We are actively engaged in the Florida medical device community and available for in-person strategy sessions, facility visits, and team training programs throughout the state. If you are a Florida-based device company looking for a local regulatory partner with national and international depth, we welcome the conversation.

International Manufacturers: US Agent and Market Access

For foreign medical device manufacturers 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 foreign manufacturers in good standing with FDA.

We have experience working with manufacturers from Europe, Latin America, Asia-Pacific, and the Middle East, navigating the specific challenges that foreign manufacturers face including 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.

Geographic Service Summary

• US nationwide: All FDA regulatory services, remote engagement, travel available for on-site work
• Southeast US / Florida: In-person engagement, facility visits, on-site consulting without travel surcharge
• Foreign manufacturers: 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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