Whole AI is a Humanity-Centered™ strategy and systems partner for enterprises navigating AI in regulated and high-stakes environments. We help leaders move from pilots to production by aligning engineering, governance, and commercialization with durable growth and trust.

Our flagship initiative, Whole AI Foundry™, is an applied architecture and governance lab for privacy-preserving AI. It spans every layer of the stack – from secure hardware enclaves and federated learning pipelines to encrypted inference, key management, and real-time monitoring – structured to meet regulatory and enterprise scrutiny from day one.

We integrate industry-specific regulatory pathways such as FDA medical device submissions under 21 CFR (e.g. 510(k), De Novo, PMA), CE Marking under the EU Medical Device Regulation (MDR), and the EU AI Act – together with standards and compliance frameworks such as ISO/IEC 42001, ISO/IEC 23894, HIPAA, and financial-services regulations. This approach ensures AI systems are audit-ready and aligned with board-level strategy.

Through strategic partnerships with DigiDaaS and Eliomedica, we bring MedTech and SaMD solutions – including AI-enabled systems where appropriate – from concept to clearance, while extending this model across financial services, law, and industrial systems.

Whole AI is not just building AI systems. We are designing the ecosystems and architectures that leaders, and society, can trust to endure.

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