Brian Binkowski

About Brian Binkowski

I am a Medical Device, SaMD, and AI/ML Quality Systems Compliance Leader with 12+ years of experience bridging advanced technology, regulatory strategy, and patient safety. My career spans roles across startups, global enterprises, and world-class healthcare institutions, where I’ve built and led Quality Management Systems, regulatory compliance strategies, and software development processes that meet the highest standards of safety, security, and innovation.At Mayo Clinic, I manage AI/ML quality and regulatory pathways, supporting clinicians and product teams to safely deploy digital health technologies. My expertise covers SaMD lifecycle compliance (IEC 62304/82304), ISO 13485, 21 CFR 820, ISO 14971 risk management, AI/ML governance (ISO 42001), and cybersecurity frameworks (HITRUST, SOC2, HIPAA, NIST, ISO 27001).Beyond compliance, I am passionate about making regulations accessible and actionable—helping teams see quality not as a burden but as a driver of trust, adoption, and innovation in healthcare.I’m also actively engaged in standards development and thought leadership through AAMI, ISO, Advamed, and FDA collaborations. I’ve published on FDA premarket submissions, presented at RAPS Convergence, and contributed to shaping best practices for AI-enabled healthcare solutions.Outside of work, I teach theology, church history, and spiritual formation, and serve as a storyteller for children’s Bible programs—building both technical systems and spiritual communities with the same commitment: excellence, clarity, and transformation.

Experience

1. Quality Systems Manager - Ai

   Mayo Clinic

   Jul 2025 — Present

   Driving safe, effective deployment of AI/ML and SaMD in healthcare by building a tiered, risk-based Quality Management System aligned with FDA and global standards.Built a tiered QMS for AI/ML aligned with ISO 42001, FDA QMSR, ISO 13485, and NIST/ISO security frameworks.Completed a QMSR gap assessment and internal audit to strengthen compliance.Supported regulatory intake and documentation for AI-enabled SaMD, including Class II software for cardiology, internal medicine, and ICU.Partnered with clinicians and product teams on design history files, risk analysis, and deployment documentation.Contributed to publications and industry best practices on AI/ML risk management and model card development.

Education

• Talbot School Of Theology

  Masters in Science and Religion

• California Polytechnic State University-San Luis Obispo

  Bachelor of Science, General Engineering; Biomedical and Industrial Manufacturing

  2006 — 2011

• Talbot School Of Theology

  Master of Arts - MA in Science and Religion

Skills

• Minitab
• 8d Problem Solving
• Quality Assurance
• Design for Manufacturing
• Excel
• Process Improvement
• Root Cause Analysis
• Public Speaking
• Fda
• Anatomy
• Microsoft Office
• Project Management
• Capa
• Lean Manufacturing
• Statistics