What We Do
Comprehensive FDA regulatory support from device classification through post-market surveillance — delivered by practitioners, not generalists.
Premarket Submissions
Navigating FDA premarket submissions requires deep knowledge of predicate strategy, substantial equivalence, and FDA reviewer expectations. We've managed 100+ submissions across device classes and know what it takes to reach clearance efficiently.
Whether you're pursuing a traditional 510(k), a De Novo request, or a full PMA for Class III devices, ADB CRO prepares submissions that stand up to FDA scrutiny.
Emerging Technology
The FDA's approach to AI/ML SaMD is rapidly evolving. The 2021 AI/ML Action Plan, Predetermined Change Control Plan (PCCP) framework, and ongoing digital health guidance have introduced significant complexity for device developers.
ADB CRO specializes in helping AI-enabled medical device companies build compliant regulatory strategies from the ground up — including SaMD risk classification, De Novo pathways, and PCCP development for adaptive algorithms.
Emergency Response
FDA Form 483 observations and Warning Letters represent significant regulatory risk. ADB CRO provides immediate, structured crisis support — with CAPA strategies delivered within 48 hours and FDA correspondence that demonstrates genuine commitment to compliance.
Section 524B Compliance
The Consolidated Appropriations Act of 2023 (Section 524B of the FD&C Act) established mandatory cybersecurity requirements for all cyber devices submitted after March 29, 2023. Non-compliant submissions are refused acceptance by FDA.
Clinical Research
Clinical evidence is a cornerstone of PMA approval and increasingly important in 510(k) submissions. ADB CRO brings full CRO capabilities to medical device clinical programs — from IDE application through final clinical report.
Quality Management
A robust Quality Management System is both an FDA requirement and a competitive advantage. ADB CRO brings operational QMS experience — not just documentation templates — to every engagement.
Detailed Service Pages
Expert-level guidance on every service we offer — covering the regulatory framework, what we deliver, and how we approach each engagement.
Predicate strategy, SE arguments, performance testing coordination, and FDA deficiency response management for Class I and II devices.
Full Service Guide48-hour CAPA strategy, root cause analysis, FDA response letter preparation, and warning letter defense. Same-day assessment available.
Full Service GuideGap analysis, QMS documentation, design controls framework, mock audits, and certification body coordination from gap to grant.
Full Service GuideModular vs. traditional PMA strategy, clinical evidence design, advisory panel preparation, and post-approval obligations management.
Full Service GuideNovel device pathway strategy, special controls development, eSTAR submission, and competitive moat positioning for first movers.
Full Service GuideStrategic question development, Pre-Sub package preparation, FDA meeting management, and post-meeting action planning.
Full Service GuideDevice classification, pathway analysis, predicate evaluation, contingency planning, and regulatory roadmap aligned to development stage gates.
Full Service GuideSR/NSR determination, IDE application preparation, clinical protocol design, IRB coordination, and Early Feasibility Study support.
Full Service GuideCAPA system builds, root cause analysis facilitation, effectiveness verification design, and FDA QSIT inspection readiness.
Full Service GuideFull QMS architecture, eQMS platform selection, SOP library, design controls framework, and FDA/ISO audit readiness for startups.
Full Service GuideClinical Research
End-to-end clinical research operations for FDA medical device programs — from study design through clinical study report and post-market surveillance.
IDE study architecture, OPC-based designs, SAP development, and SR/NSR determination for 510(k) and PMA clinical programs.
Learn MoreInvestigator qualification, site initiation visits, protocol training, and ongoing monitoring with source data verification.
Learn MoreFDA 21 CFR Part 812 compliant protocols, informed consent forms, IRB submission packages, and protocol amendments.
Learn MoreIDE applications, IDE amendments, annual progress reports, UADE reporting, and FDA correspondence management.
Learn MoreCRF design, DMP development, 21 CFR Part 11 EDC compliance, SAP execution, and submission-ready TLF production.
Learn MoreICH E3-structured CSRs, 510(k) clinical sections, PMA clinical evidence summaries, and literature-based clinical evidence packages.
Learn MorePMS plans, MDR complaint handling, 21 CFR 822 surveillance, PMCF study design, and EU MDR PMSR/PSUR development.
Learn MoreProduct Development
Regulatory support for medical device development — from feasibility and design controls through labeling compliance and packaging validation.
21 CFR 820.30 design control implementation, ISO 14971 risk management files, DHF architecture, and V&V protocol development.
Learn MoreDesign history integration for feasibility work, bench testing protocols, failure mode analysis, and feasibility-to-verification transition planning.
Learn MoreUse-related risk analysis, formative and summative usability studies, HFE reports for 510(k) and PMA submissions under FDA's 2016 guidance.
Learn MoreDHF gap assessment, document remediation, traceability matrix development, and pre-submission DHF readiness review.
Learn MoreIFU writing, 21 CFR 801 compliance, ISO 15223 symbols, UDI-DI requirements, and device label review against cleared indication.
Learn MoreISO 11607 sterile barrier validation, ASTM F88/F1140 testing coordination, accelerated aging, and distribution simulation programs.
Learn MoreQuality Services
Quality management, inspection readiness, supplier controls, and compliance remediation for FDA-regulated medical device manufacturers.
21 CFR 820 and ISO 13485 gap assessment — document review, staff interviews, records sampling — with prioritized remediation roadmap.
Learn MoreMock FDA QSIT inspections, ISO 13485 internal audits, audit report writing, and mock inspection programs for inspection readiness.
Learn MoreFDA import detention response, import alert review strategy, reconditioning proposals, and admission documentation for foreign manufacturers.
Learn More21 CFR 806 notification, recall strategy, effectiveness checks, CAPA development, and FDA recall closure documentation.
Learn MoreFDA GMP and ISO 13485 certification readiness, Pre-Approval Inspection preparation, mock GMP audits, and document gap remediation.
Learn MoreMDSAP task-based gap assessment, FDA/Health Canada/TGA/PMDA/ANVISA multi-jurisdiction readiness, and mock MDSAP audit.
Learn MoreISO 19011 lead auditor training, annual audit program design, process-specific checklists, and external audit execution support.
Learn More21 CFR 820.50 supplier quality procedure, critical supplier classification, supplier qualification audits, and approved supplier list management.
Learn MoreRegulatory Services
Registration, classification, FDA meetings, labeling compliance, and regulatory risk management for US and international device programs.
FDA US Agent designation under 21 CFR 807.40, establishment registration, device listing management, and active FDA correspondence routing.
Learn MoreDevice classification analysis, 513(g) request preparation, FDA response interpretation, and regulatory strategy development from classification outcome.
Learn MoreQ-Sub, Pre-IDE, Pre-PMA meeting packages with specific questions and proposed answers. FDA meeting participation and minutes review.
Learn MoreOff-label promotion risk assessment, promotional material review, claim substantiation analysis, and promotional review SOP development.
Learn MoreFDA FURLS establishment registration, device listing, annual renewal management, and 510(k) exempt status determination.
Learn MoreClassification analysis, predicate selection risk, data package gap analysis, and regulatory strategy development for new device programs.
Learn MoreCybersecurity
Section 524B compliance, SBOM development, risk assessments, HIPAA, and incident response for connected medical device manufacturers.
Business associate determination, ePHI data flow mapping, Security Rule risk analysis, gap assessment, and BAA development for device manufacturers.
Learn MoreSection 524B cybersecurity plan, SBOM generation, secure development lifecycle, vulnerability management, and premarket cybersecurity submission documentation.
Learn MoreThreat modeling (STRIDE), vulnerability assessment, CVSS scoring with clinical context, IEC 62443, and residual risk documentation for FDA submission.
Learn MoreCoordinated vulnerability disclosure programs, postmarket cybersecurity monitoring, incident classification, and FDA regulatory notification procedures.
Learn MoreGet Started
Tell us about your device and where you are in the process. We'll tell you exactly what we'd do.