Founder & Principal Consultant
Andre D. Butler, CQA, CCRP — Founder & Principal Consultant
28+ years in FDA-regulated medical devices · 50+ client engagements · 150+ products launched · 15+ FDA 510(k) clearances · Class I–III, SaMD, combination products, and IVDs
Andre Butler founded ADB Consulting & CRO Inc. in 1999 and has spent nearly three decades inside FDA-regulated product development — from clinical data systems on Medtronic's TALENT stent graft program (45,000+ implants worldwide) and managing the VALOR pivotal IDE trial, to an 11-year embedded engagement at HeartWare directing quality and validation programs for the HVAD Class III LVAD through its 2012 PMA approval and Medtronic's $1.1B acquisition.
That foundation extends across every service ADB offers today. In regulatory submissions, Andre has authored 15+ cleared 510(k)s and prepared PMA, IDE, Pre-Submission, and Breakthrough Device Designation packages spanning Class I–III devices, SaMD, IVDs, and combination products. In FDA enforcement response, he has served as the primary FDA point of contact for multiple manufacturers facing Form 483 observations and warning letters — authoring agency-accepted responses, including a 10-observation 483 response accepted in 2025, and leading the CAPA and remediation programs behind them. In quality systems, he has built and remediated QMS infrastructures under 21 CFR 820/QMSR and ISO 13485 — including two first-pass MDSAP certifications — and serves as a contract ISO 13485 lead assessor for a certification body. In software and cybersecurity, he co-led Abbott's divisional integration of FDA cybersecurity guidance and IMDRF N60 into design controls across FreeStyle Libre, MitraClip, and Alinity, and works fluently in IEC 62304 lifecycles, AI/ML SaMD classification, and Section 524B documentation.
His engagement history includes Medtronic, HeartWare, Abbott, Covidien, Mitralign, Avedro (the first FDA-approved corneal crosslinking system), Cohero Health, Nipro Diabetes Systems, PTS Diagnostics, and dozens of early-stage and mid-size device companies — from Class III structural heart programs to connected-health platforms and point-of-care diagnostics.
Andre holds dual B.S. degrees in Computer Science and Microbiology (Florida Atlantic University), is a Certified Quality Auditor (ASQ) and Certified Clinical Research Professional (SoCRA), and is a published clinical contributor (Journal of Vascular Surgery, 2002). That dual software-and-life-sciences foundation is why ADB works fluently across SaMD, cybersecurity (Section 524B), and traditional device submissions.