Navigate the EU AI Act, ISO 42001, and FDA AI requirements with a consultant who bridges quality systems, regulatory affairs, and artificial intelligence.
The Challenge
Organizations across healthcare, financial services, manufacturing, and defense are deploying AI at an accelerating pace. But the governance structures needed to manage AI risk, satisfy regulators, and maintain stakeholder trust are lagging far behind the technology itself.
High-risk AI system requirements take effect August 2, 2026. Most organizations haven't started preparing.
ISO 42001, NIST AI RMF, FDA AI/ML guidance, sector-specific requirements — navigating the landscape requires specialized expertise.
Boards and executives are increasingly liable for AI decisions. Most lack the governance structures to demonstrate due diligence.
The pressure to deploy AI fast is real. But cutting corners on governance creates existential risk — regulatory, reputational, and operational.
Services
Whether you're conducting your first AI risk assessment or building an enterprise-wide governance program, every engagement is structured to meet you where you are and move you toward defensible, auditable AI governance.
$15,000 – $75,000
A comprehensive inventory and risk classification of your organization's AI systems. Identifies governance gaps, maps regulatory exposure, and delivers a prioritized remediation roadmap. The essential first step for organizations that don't yet have visibility into their AI landscape.
$5,000 – $10,000 / month
Ongoing AI governance advisory for organizations actively building or refining their governance programs. Provides consistent access to senior-level guidance on framework implementation, regulatory interpretation, policy development, and audit preparation without the overhead of a full-time hire.
$15,000 – $25,000 / month
C-suite AI leadership for organizations that need strategic direction without the $300K–$500K+ total compensation of a full-time CAIO. Sets AI strategy, chairs governance committees, manages regulatory relationships, and builds internal capability — typically engaging 2–4 days per month.
Not sure which service fits? Start with a conversation.
Schedule a free 30-minute consultationWhy Regulated AI Consulting
Most AI governance consultants come from cybersecurity or data science. Jared Clark comes from quality systems and regulatory affairs — the disciplines that AI governance actually requires. The combination of legal training, quality management certification, regulatory expertise, and project management methodology creates an approach that is uniquely suited to helping regulated organizations build defensible AI governance programs.
When you engage Regulated AI Consulting, you work directly with a senior practitioner — not a team of junior consultants learning on your dime. The frameworks integrate with your existing quality management systems rather than creating parallel bureaucracies.
Legal analysis of regulatory requirements, contract structures for AI governance engagements, and compliance interpretation that holds up under audit scrutiny.
ASQ-certified quality systems expertise. AI governance is, at its core, a quality management challenge — and this credential proves the methodology to solve it.
RAPS-certified regulatory affairs expertise spanning FDA, EU MDR, and now EU AI Act. Knows how regulators think because he's worked on their side of the table.
PMI-certified project management for governance implementations that finish on time and within scope — not open-ended consulting engagements that drift.
Industries
Every regulated industry has unique AI governance requirements. Our approach combines cross-industry best practices with deep domain expertise in the sectors where the stakes are highest.
FDA AI/ML guidance, clinical decision support oversight, drug discovery AI governance, and GxP-aligned AI management systems.
Learn moreModel risk management, algorithmic fairness, explainability requirements, and AI governance frameworks aligned with OCC, Fed, and SEC expectations.
Learn moreAI-enabled quality control, predictive maintenance governance, supply chain AI oversight, and integration with ISO 9001 quality management systems.
Learn moreDoD AI ethics principles, NIST AI RMF alignment, autonomous systems governance, and AI governance for government contractors and cleared environments.
Learn moreRegulatory Landscape
The AI regulatory environment is evolving rapidly. We help organizations understand which frameworks apply to their specific situation and build governance programs that satisfy multiple regulatory requirements simultaneously.
The world's first comprehensive AI regulation. High-risk AI systems must demonstrate conformity with requirements for risk management, data governance, transparency, human oversight, and cybersecurity. Organizations that sell into or operate within the EU must prepare now — the enforcement window is narrowing.
EU AI Act readiness assessmentThe international standard for AI management systems. Provides a structured framework for establishing, implementing, maintaining, and continuously improving AI governance. Particularly valuable for organizations seeking internationally recognized third-party certification of their AI governance programs.
ISO 42001 implementation guidanceThe FDA's evolving framework for AI and machine learning in medical devices, drug development, and clinical decision support. Includes predetermined change control plans, real-world performance monitoring, and Good Machine Learning Practice principles.
FDA AI compliance guidanceThe U.S. federal AI risk management framework organized around Govern, Map, Measure, and Manage functions. While voluntary, NIST AI RMF is increasingly referenced by regulators and procurement requirements as the baseline for responsible AI practices.
Framework design servicesOrganizations deploying high-risk AI systems need 12+ months to prepare. If you haven't started your AI use inventory, gap analysis, and remediation planning, the time is now. We help you build a compliance program that meets the deadline — and builds lasting governance capability.
FAQ
Start with a free 30-minute consultation. We'll discuss your organization's AI landscape, regulatory exposure, and what a governance program looks like for your specific situation. No sales pitch — just a candid assessment of where you stand and what comes next.
Or email support@certify.consulting