Felaris offers you your own Chief AI Officer for AI strategy and governance

When a regulated company needs AI governance at the executive level, the options are an expensive permanent hire at, an AI consultant with no operating authority, or a senior executive who has built AI strategy and governance in regulated environments and can embed in your leadership team from day one. We provide the third option.

Our Principal Consultants have led AI strategy development and managed global technology organizations under active FDA and EU MDR oversight, built compliance programs from the ground up, and managed data governance across regulated manufacturing, medical device, and pharmaceutical environments. 

AI governance and the implementation of AI business foundation services is an extension of those disciplines.

The fractional CAIO reports to the CEO or board alongside other C-suite members. AI strategy development tied to business objectives and regulatory constraints, AI governance framework design (policies, risk classification, acceptable use, vendor evaluation), data readiness assessment, and internal capability building so the organization can sustain AI governance after the engagement concludes.

AI governance in FDA-regulated and SOX-audited companies is structurally different from AI governance at unregulated companies. Felaris aligns AI programs to FDA 21 CFR Part 11, EU AI Act risk classification, ISO 13485, SOX ITGC controls, GAMP 5 Category 5 validation, and NIST AI Risk Management Framework (AI RMF 1.0).

Pre-revenue AI stage, stalled pilots requiring executive ownership, M&A integration with mixed AI maturity across acquired entities, or board-level AI oversight without permanent headcount. Exit criteria defined at engagement start. The CAIO role converts to a permanent hire or dissolves by design when the internal team can sustain the governance.

• Full-Time Interim: On-site or remote, 3-12 month engagements for complete CAIO role coverage. Best for organizations in active transition, crisis, or major initiative execution.
• Fractional/Part-Time: 1-3 days per week for organizations needing strategic leadership without a full-time commitment. Ideal for growth-stage companies and post-restructuring environments.
• Advisory Retainer: Ongoing strategic guidance and decision support for existing IT leadership. Best for organizations with capable IT teams that need senior-level perspective and oversight.

Medical device manufacturing, pharmaceutical and life sciences, regulated manufacturing, warehouse/distribution, industrial manufacturing, growth-stage companies

Organizations with $50M to $500M in revenue in medical device, pharmaceutical, CDMO, manufacturing, and distribution across the US, Caribbean, and Europe.

When the data, process, or governance foundation requires remediation before AI can move to production, Felaris delivers that work through AI Business Foundation Services.

Every CAIO engagement begins with an AI governance and readiness assessment: data, process, technology, organizational, and governance maturity. The assessment determines scope, timeline, and engagement structure. Contact us to schedule an initial conversation.