Global Regulatory & Clinical Experts for MedTech and Healthcare Innovators
From FDA submissions to ISO certifications and clinical trial support, ADB Consulting helps you bring your medical device to market—faster, safer, and fully compliant.
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Regulatory Strategy
Navigate FDA, ISO, and international requirements with confidence through expert-guided regulatory planning and submission support.
Clinical Trial Management
Design, manage, and monitor medical device clinical trials from start to finish—with complete data oversight and compliance assurance.
Quality Systems & Compliance
Build audit-ready QMS frameworks, manage supplier audits, and ensure ongoing ISO 13485 and 21 CFR Part 820 compliance.
About ADB Consulting
Trusted by 100+ Clients Across the Globe
Since 2004, ADB Consulting & CRO Inc. has helped medical device and healthcare companies navigate the complex landscape of regulatory compliance, clinical trials, and quality systems. Our cross-functional team brings deep expertise in FDA/ISO regulations, QMS setup, cybersecurity, and product development.
150+ Devices Launched
50+ Regulatory Submissions
100% Client Confidentiality & Compliance
Our Services
Clinical Research (CRO Services)
Trial design & site management
Clinical monitoring & reporting
Data management & post-market surveillance
Successful Satisfied
Projects Customers
Successful Satisfied
Projects Customers
142k
Successful Projects
1859
Satisfied Customers
Successful Satisfied
Projects Customers
Regulatory Consulting
FDA 510(k), PMA, IDE, De Novo submissions
ISO/MDR/MDSAP global compliance
Labeling, risk assessment & strategy
Quality Systems & Compliance
QMS development (ISO 13485, 21 CFR Part 820)
CAPA, complaints, audits & gap assessments
Supplier management & training
Cybersecurity & Data Protection
HIPAA audits, incident planning, and secure systems
Validation of digital health & medical software
Cyber risk & cloud compliance
Product Development Support
Risk analysis, DHF authorship, human factors
Package & labeling design
Regulatory roadmap development
Our Team
Andre Butler
CEO
Jose Cabrera
VP of Regulatory
Dave Bucknam
VP of Operations and Manufacturing
Jeffrey Bembry
Directory Of Quality
Why Clients Choose ADB
Deep expertise in MedTech regulations
Personalized support across the full product lifecycle
Global reach with U.S. FDA & EU MDR experience
End-to-end CRO services tailored for medical device companies
Dedicated experts in regulatory strategy, QMS, validation, and cybersecurity
Trusted by 100+ clients globally with 150+ successful device launches
Ready to Simplify Compliance?
Don’t let regulations delay your launch.
Whether you're preparing your first FDA submission or scaling into new global markets, our team is ready to guide you.
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