Michael Craige, Ph.D.

Founder, Scientist & CEO at Precoh | Building RegOS: The Regulatory Execution Operating System Layer for Clinical AI.

United States

About

Founder, Scientist and CEO of Precoh. Building RegOS: the regulatory execution operating system layer for clinical AI | FDA SaMD · EU MDR · EU AI Act · IMDRF requirements into an executable, auditable evaluation platform. Health systems, AI and MedTech vendors, and government health regulators use RegOS to produce tamper-evident, audit-defensible evidence the moment a clinical AI decision is made. My background covers biomedical informatics, health services, clinical RWE, AI regulatory practice, bioinformatics and computational biology, and software engineering - the disciplines this problem requires. I also have interest in quantum computing. I have conducted both wet-lab and computational research across multiple biomedical domains, including cancer, neurology, sickle cell disease, and multiple myeloma. - PhD, Biomedical Informatics, Rutgers University - 2021 NSF Computing Innovation Fellow (CIFellows) - NSF I-Corps and SOSV Venture Fellow - Peer-reviewed publications in Nature and PubMed-indexed journals - Clinical informatics, computational methods, and real-world evidence (EHR Data Expert) - Active engagements across the United States, United Kingdom, and United Arab Emirates Deep working knowledge of FDA's Predetermined Change Control Plan Final Rule (December 2024), the EU AI Act's Annex III high-risk medical AI obligations, and IMDRF Good Machine Learning Practice. The regulatory infrastructure layer between clinical AI and the regulators evaluating it is the work that has to get built right now. Precoh RegOS ensures every clinical AI model can be evaluated, approved, and scaled with confidence - ad hoc clinical regulatory validations replaced with a structured, deployable, defensible, and scalable platform. Precoh AI | RegOS | precoh.a

Experience

  • Precoh (4 yrs 8 mos)
    • Founder & CEO
      Jun 2025 - Present · 1 yr 1 mo

      The regulatory AI Layer that makes clinical AI Deployable, Defensible, and Scalable.

    • Founder & Principal Architect
      Nov 2021 - Jun 2025 · 3 yrs 8 mos

  • Data Scientist Leader at National Institute on Minority Health and Health Disparities (NIMHD)
    Jan 2026 - Present · 6 mos

  • Founder & Scientific Director at CiDrep SickKids Foundation
    Aug 2017 - Present · 8 yrs 11 mos

    CiDrep SickKids Foundation supports sick kids in two complementary ways: by funding direct care for families when insurance and other resources are exhausted, and by conducting equity-first computational research to help sick kids receive earlier, fairer care.

  • Deputy Director at American Society of Hematology
    Apr 2024 - Jun 2025 · 1 yr 3 mos

    Led Research Informatics & Data Science at the ASH Research Collaborative Data Hub.

  • Adjunct Instructor & Mentor at Interior Northeast I-Corps Hub (IN I-Corps)
    2022 - 2025 · 3 yrs