Andre Butler

Senior Medical Device Regulatory & Quality Consultant with 20+ years of experience supporting FDA-regulated products across regulatory affairs, quality systems, software/SaMD, design controls, and clinical research. Skilled in 510(k), PMA, ISO 13485, QMSR, EU MDR/IVDR, IEC 62304, ISO 14971, MDSAP, FDA 483 responses, and QMS remediation for Class I–III devices, SaMD, IVDs, and combination products. Proven track record leading submissions, audit readiness, CAPA programs, and compliance strategy for both startups and established manufacturers.