At Right Brain Left Brain Consulting, we offer a complete suite of regulatory solutions designed to ensure compliance with the FDA, ISO 13485, MDSAP, and other global standards. Our services are built to meet the specific needs of businesses at any stage—whether you’re preparing for your first audit, maintaining certifications, or addressing findings from regulatory authorities.

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Our comprehensive Offerings

Customized Engagements:
We provide options for:

  • One-Time Audits: Perfect for pre-certification readiness or addressing findings.
  • Ongoing Support Plans: Affordable packages for startups or small businesses, including annual maintenance audits.
  • Full-Service Audits: Comprehensive evaluations covering all regulatory areas.
Let us help you navigate the FDA audit process with confidence, clarity, and efficiency.

AI-Enhanced Audit Support
FDA Mock Audits
MDSAP Audit Support
Internal Audit Support
Post-Audit Remediation
Annual Maintenance Audits
Gap-Analysis and Pre-Audit Assessments