Andre Butler — FDA Regulatory Affairs Consultant with 20+ Years Experience

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 — 20+ Years

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

Jose Cabrera

VP Regulatory Affairs — 35 Years

Pre-market submissions, IDE programs, regulatory strategy across all device classes. Extensive experience with FDA reviewer interactions and meeting strategy.

Dave Bucknam

VP Operations — 30 Years

ISO 13485 Lead Auditor. QMS development, GMP compliance, MDSAP preparation, and FDA facility inspection readiness across manufacturing environments.

Jeffrey Bembry

Director of Quality — 25 Years

CAPA systems, design controls, internal audit programs, and quality system gap remediation. Extensive FDA QSIT inspection experience from the investigator and manufacturer perspective.

Pedro Barzola

Physician Education — 25 Years

Clinical study operations, physician training, human factors evaluation, and clinical site management. Bridges the clinical and regulatory requirements in device development programs.