Business Details
Your Trusted Partner for Medical Device Compliance
Adb Consulting & Cro Incs Inc. is a global leader in medical device development and regulatory compliance, offering end-to-end clinical research, regulatory, quality assurance, and cybersecurity services. With decades of experience, we guide clients from concept to commercialization, ensuring their innovations meet rigorous safety and compliance standards. Our team has supported 100+ customers worldwide, launched 150+ products, and completed 50+ regulatory submissions, demonstrating a proven track record in advancing medical technologies.We prioritize patient safety, regulatory excellence, and client-centric solutions, fostering global health resilience and inclusivity. Our collaborative approach integrates strategy, research, and operations to transform ideas into life-changing healthcare solutions.
Services
Clinical Trial Design
Site Selection and Management
Protocol Development
Regulatory Submissions
Data Management and Analysis
Clinical Study Reports
Post-Market Surveillance
Product Development Services
Quality Service Gap Assessment
Cybersecurity Solutions
Highlights and features
- Proven track record in regulatory and clinical excellence with 50+ regulatory submissions.
- Integrated solutions for all phases of medical device product development.
- Expertise across therapeutic areas and global markets, including FDA and EU compliance.
- Client-focused approach prioritizing innovation, collaboration, and responsiveness.
- Commitment to quality and compliance with FDA, ISO, and international standards.
What people say
Proven expertise in FDA quality systems
Exceptional problem-solving abilities
Dedicated and knowledgeable team
Timely and thorough responses
Client-focused approach
Services
Clinical Trial Design
We design scientifically rigorous clinical trials aligned with FDA and ICH GCP standards. Our experts define objectives, endpoints, and sample sizes to ensure regulatory compliance and statistical validity. Services include protocol development, risk management, and site selection to optimize data quality and patient safety.
Regulatory Submissions
Our team prepares and submits regulatory documentation for FDA and international approvals. We specialize in IDE applications, 510(k) submissions, and PMAs, ensuring compliance with evolving standards. We also manage post-submission communications to expedite approvals and minimize delays.
Quality System Development
We build FDA- and ISO-compliant quality management systems from scratch, including design controls, CAPA implementation, and audit support. Our services ensure adherence to 21 CFR Part 820 and ISO 13485, enabling clients to pass inspections and maintain continuous compliance.
Cybersecurity Risk Assessments
We identify vulnerabilities in connected medical devices through penetration testing, code reviews, and threat modeling. Our assessments align with FDA and EU MDR requirements, providing actionable mitigation strategies to safeguard patient data and device functionality.
Product Development Services
We support medical device development from concept to market, including design controls, prototyping, and human factors engineering. Our services integrate regulatory strategy early to reduce redesign risks and accelerate time-to-market while ensuring compliance with global standards.
Questions
What services does ADB CRO offer?
We provide clinical research, regulatory consulting, quality assurance, product development, and cybersecurity services for medical device manufacturers.
How does ADB CRO ensure regulatory compliance?
We align services with FDA, ISO 13485, EU MDR, and international standards, offering gap assessments, audit support, and submission preparation.
Can ADB CRO assist with global market entry?
Yes, we support regulatory approvals in the U.S., EU, Canada, Australia, and Brazil through MDSAP and CE marking strategies.
What industries do you specialize in?
We focus exclusively on medical device development, including diagnostics, digital health, and therapeutic technologies.
How do you handle cybersecurity for connected devices?
We conduct risk assessments, penetration testing, and HIPAA compliance audits to secure data and meet FDA premarket cybersecurity requirements.
