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.
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
Using advanced custom designed RBLB AI-tools, we perform faster, more thorough assessments of CAPAs, NCs, and SOPs. AI-enhanced solutions allow us to provide actionable insights and compliance recommendations at a fraction of the time and cost.
Privacy and security are provided with our custom designed sanitizer.
Our tools are cloud-native and can run efficiently within cloud clusters. In fact, cloud integration is one of the key benefits, as it allows for scalability and real-time collaboration across teams, no matter where they are located. By running in the cloud, we also ensure that the system can handle large data sets, analyze them quickly, and deliver insights without requiring significant on-site infrastructure.
FDA Mock Audits
Prepare with confidence. Our experienced team conducts realistic FDA mock audits to identify gaps in your compliance and provide actionable recommendations to address them.
MDSAP Audit Support
From initial certification to the ongoing three-year audit cycle, we ensure your compliance across multiple regulatory jurisdictions. Our tailored approach helps you manage the unique requirements of countries like the US, Canada, Brazil, Australia, and Japan.
Internal Audit Support
We conduct thorough internal audits, focusing on critical areas like CAPAs, Risk Management, Post-Market Surveillance, Design Controls, and Supplier Management to ensure compliance before an external review.
Post-Audit Remediation
Facing findings from an audit? We specialize in creating comprehensive response plans and executing corrective actions to address non-compliance efficiently.
Annual Maintenance Audits
Stay compliant year-round. We help you manage ongoing compliance requirements through annual audits that align with your certification timelines.
Gap-Analysis and Pre-Audit Assessments
Our experts conduct deep-dive assessments into your quality systems and processes, identifying gaps and providing prioritized solutions to ensure a smooth audit experience.