Leadership
ADB engagements are staffed from the practice groups below. The practice director named in your SOW is your FDA-facing lead for the life of the engagement.
Talk to a Practice DirectorBy Regulatory Function
510(k), De Novo, PMA, 513(g), and Pre-Submission strategy and preparation, from predicate analysis through FDA clearance.
Practice Director, Regulatory Submissions
View practice →IDE strategy, U.S. Sponsor of Record responsibilities, early feasibility studies, and Breakthrough Device requests.
Practice Director, Clinical & IDE
View practice →QMSR and ISO 13485 gap assessments, FDA 483 and Warning Letter response, and procedure/records audits.
Practice Director, Quality & Compliance
View practice →AI/ML-enabled SaMD submissions, Predetermined Change Control Plans, and Section 524B cybersecurity documentation.
Practice Director, Digital Health & Cybersecurity
View practice →By Device Area
Practice Director, Clinical & IDE (Cardiovascular lead)
View device area →Practice Director, Regulatory Submissions (Surgical & Orthopedic lead)
View device area →For Non-U.S. Manufacturers
U.S. Agent, official correspondent, and IDE Sponsor of Record services for manufacturers outside the United States.
Program Director, International Sponsors
View program →How We Work
Your practice director is named in the proposal and statement of work before the engagement starts — never assigned after the fact.
Team size is set by the scope of work and written into the SOW, so you are not paying for a bench you do not use and are not left with a single point of failure.
Where a program calls for device-area depth ADB does not carry in-house, ADB engages a domain specialist with that experience and names them in the SOW — the practice director remains accountable for the result.
Get Started
Tell us about your device and we'll route you to the right practice group — no sales pitch, no obligation.