Founder & Principal Consultant
Andre Butler
25 Years — FDA Regulatory Affairs · Clinical Research · AI/ML SaMD
Andre Butler founded ADB Consulting & CRO Inc. after more than two decades leading regulatory strategy for medical device companies across every device class and therapeutic area. His experience spans the complete regulatory lifecycle — from device classification and pre-submission strategy through 510(k), De Novo, and PMA preparation, clinical trial management under IDE programs, ISO 13485 QMS implementation, and FDA 483 emergency response.
Andre has particular depth in three high-growth areas: AI/ML Software as a Medical Device (SaMD) under FDA's evolving regulatory framework, cybersecurity compliance under Section 524B of the FD&C Act including SBOM development and premarket cybersecurity documentation, and Predetermined Change Control Plan (PCCP) strategy for adaptive AI/ML algorithms. He has managed regulatory programs from seed-stage startups through established manufacturers, providing the senior regulatory expertise that was previously available only to larger organizations.
Based in Sunrise, Florida, Andre serves clients nationwide and internationally as US Agent for foreign manufacturers seeking FDA market access.
Vice President, Regulatory Affairs
Jose Cabrera
35 Years — Premarket Submissions · Regulatory Strategy · FDA Liaison
Jose Cabrera brings 35 years of medical device regulatory affairs experience to the ADB Consulting team, with a career spanning pre-market submissions across all device classes, IDE program management, and strategic regulatory advisory for device manufacturers navigating complex classification and pathway decisions. His depth of experience with FDA reviewer interactions and pre-submission meeting strategy is among the most extensive in the field.
Jose leads complex 510(k) and PMA submission programs for ADB Consulting clients, with particular expertise in submission strategy for devices with challenging predicate landscapes or novel technological characteristics requiring De Novo classification. His FDA meeting preparation work — including Pre-Sub, Pre-IDE, and Pre-PMA meeting packages — consistently produces specific, actionable FDA responses that reduce submission uncertainty.
Vice President, Operations
Dave Bucknam
30 Years — ISO 13485 Lead Auditor · QMS · GMP · MDSAP
Dave Bucknam is an ISO 13485 Lead Auditor with 30 years of experience in medical device quality management systems, GMP compliance, and regulatory facility inspection readiness. His background spans both the manufacturer and auditor perspective — he has built QMS systems from scratch for early-stage device companies and conducted third-party audits for manufacturers pursuing ISO 13485 certification and MDSAP recognition.
Dave leads ADB Consulting's QMS development, gap assessment, and GMP certification preparation services. His mock FDA QSIT inspection program — conducted using the actual FDA investigation methodology — has helped multiple clients achieve clean FDA inspection outcomes by identifying and closing gaps before investigators arrive.
Director of Quality
Jeffrey Bembry
25 Years — CAPA · Design Controls · Internal Audit · FDA 483 Response
Jeffrey Bembry brings 25 years of medical device quality system experience, with deep expertise in CAPA implementation, design controls, internal audit program design and execution, and FDA 483 observation response. His experience spans quality system management for Class II and Class III device manufacturers and hands-on experience with FDA QSIT inspections from both the investigator and company side.
Jeffrey leads ADB Consulting's quality systems practice — CAPA remediation, design history file assessment and gap closure, and mock FDA inspection programs. His approach combines regulatory rigor with operational practicality: quality systems that satisfy FDA's requirements and that actually function in real manufacturing environments.
Physician Education & Clinical Operations
Pedro Barzola
25 Years — Clinical Research · HFE · Physician Training · Site Management
Pedro Barzola brings 25 years of experience in clinical research operations, physician education, and human factors evaluation for medical devices. His background spans clinical site management for IDE studies, physician proctoring and training program development, and usability engineering — bridging the clinical and regulatory requirements that shape both device design and submission strategy.
Pedro leads ADB Consulting's clinical research operations and human factors engineering programs. His physician education background provides a unique perspective on use-related risk analysis — understanding how devices are used in actual clinical practice, not just in controlled evaluation conditions, is essential for building HFE programs that reflect real-world risk.