Andre D. Butler, CQA, CCRP — Founder & Principal Consultant

FDA Submission Mastery

100+ submissions across 510(k), PMA, De Novo, IDE, and Pre-Sub. Deep familiarity with FDA reviewer expectations, deficiency patterns, and clearance strategy.

AI/ML SaMD Specialist

Among the first generation of regulatory consultants with deep expertise in FDA's evolving AI/ML framework, PCCP development, and SaMD risk classification.

Crisis Response Expert

Proven track record turning 483 observations and Warning Letters into resolved compliance situations — with structured CAPA strategies delivered within 48 hours.

Cybersecurity Compliance

Specialist in Section 524B implementation — SBOM, threat modeling, and cybersecurity premarket documentation for connected medical devices.

Clinical Research Operations

End-to-end CRO capabilities from study design through IDE submission, IRB coordination, site management, and clinical study report preparation.

Quality Systems

ISO 13485 QMS design and implementation — SOP libraries, CAPA processes, design controls, and audit readiness for FDA inspection.

Andre Butler

Founder & Principal Consultant — 28+ Years

FDA regulatory strategy, 510(k)/PMA/De Novo submissions, AI/ML SaMD, cybersecurity Section 524B, FDA 483 and Warning Letter response.