At Right Brain – Left Brain Consulting, we believe in empowering businesses to not just survive but thrive, even in the most challenging economic climates. With a focus on cost efficiency, operational excellence, and regulatory compliance, we deliver AI-enhanced solutions that seamlessly bridge cutting-edge technology with deep industry expertise.

What sets us apart isn’t just our tools or techniques—it’s our people-centered approach. We balance technical precision with emotional intelligence, building trust, sharing knowledge, and fostering collaboration with every client. Our team doesn’t just solve problems; we co-create solutions that are driven by your teams and embraced by your organization. We’re not consultants in the traditional sense—we’re your strategic partners, dedicated to creating lasting change.

Our consultants bring over 100 years of collective experience in operations, quality systems, Lean Six Sigma, and regulatory compliance across medical device, pharmaceutical, and other highly regulated industries. But we also bring something more: a passion for transforming businesses from the inside out. We understand that true success isn’t just measured in metrics, but in the pride and purpose of the people who drive those numbers.

We specialize in turning challenges into opportunities and teams into communities. Whether it’s improving operational efficiency, achieving regulatory compliance, or executing seamless turnarounds, we focus on solutions that not only improve business outcomes but also inspire cultural shifts. Our clients don’t just see short-term gains—they experience transformations that turn jobs into careers and create environments where people can excel.

At Right Brain Left Brain Consulting, we pride ourselves on blending the best of both worlds: the technical expertise to solve complex challenges and the emotional intelligence to ensure those solutions resonate. Together, we build pathways to success that are as sustainable as they are impactful.

Ready to see what’s possible? Let’s innovate, inspire, and transform—together.

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Our Expertise

  • AI-Enhanced Regulatory Compliance Solutions
    Staying compliant is non-negotiable, but it doesn’t have to break the bank. Our innovative tools streamline the auditing process for CAPAs, NCs, and SOPs. By combining AI-enhanced technology with expert human oversight, we deliver faster, more accurate analyses and actionable recommendations to ensure full compliance with FDA, ISO 13485, and ISO 14971 standards.
  • Lean Six Sigma and Operations Excellence
    We help organizations reduce operational costs and boost efficiency by identifying and eliminating waste, optimizing workflows, and implementing sustainable improvements. Our proven methodologies ensure you’re ready to weather any storm while maintaining top-tier quality and customer satisfaction.
  • AI-Enhanced Project Management
    From FDA remediation and M&A integrations to cost-savings initiatives and quality system projects, we use AI-driven insights to deliver faster, smarter project execution. Our AI tools provide predictive analytics, risk assessments, and real-time reporting, ensuring your projects stay on track, within budget, and aligned with your strategic goals.
Stephanie Allison | CEO Right Brain Left Brain

Stephanie Allison

CEO Right Brain Left Brain

Certified AI Prompt Engineer | M&A Integration | Quality & Operational Leadership Expert | LSS MBB | ChE

Stephanie Allison has over 30 years of experience leading operational transformations across the nuclear, chemical, and medical device industries. As a Lean Six Sigma Master Black Belt and certified AI Prompt Engineer, she excels in process optimization, M&A integration, and regulatory compliance. Stephanie is also pursuing certification in Python to enhance her technical capabilities further.

Since founding Right Brain Left Brain Consulting in January 2013, Stephanie has successfully driven value creation, EBITDA improvement, and operational excellence for private equity-backed and large organizations. Clients such as Zimmer Biomet & Corin Group, who have benefitted from her strategic approach, leveraging her expertise in Lean Six Sigma and Smartsheet superuser capabilities.

Brian Robinson

Brian Robinson

MAOL, LSSBB, CLA Principal Consultant, HR and ISO 13485 Auditing

Brian Robinson is a seasoned consultant with over 30 years of leadership in human resources, quality management, and project management. A Lean Six Sigma Black Belt and Certified Lead Auditor in ISO 13485, Brian specializes in process improvement, HR, and regulatory compliance.

A veteran of the U.S. Navy, Brian honed his skills in managing large-scale projects, training, and quality systems. His experience includes leading quality remediation efforts, CAPA processes, and regulatory compliance strategies across multiple industries, including medical devices. He has a proven track record in building cross-functional teams and optimizing operations through Lean and Six Sigma methodologies.

Ed Wilham

Principal Consultant, OpEx, Regulatory and Pharm

Edward “Ed” Wilham brings over 20 years of experience driving transformation across medical devices, healthcare, and life sciences industries. As Principal Consultant at RBLB, Ed leverages his extensive background in product development, quality systems, regulatory compliance, and process optimization to deliver tailored solutions that enhance business performance.

Notable achievements include leading FDA remediation efforts for Zimmer Biomet and driving design control automation for Meridian Medical Technologies (a Pfizer company), ahead of schedule. He has also played key roles in securing EU MDR and IVDR certification for Hologic and guiding complex regulatory compliance initiatives for global organizations. His leadership in M&A integration for Corin post-acquisition of OMNI spanned three countries, involving over 30 projects, including regulatory compliance and FDA remediation.

Brian Robinson

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Brian Robinson is a seasoned consultant with over 30 years of leadership in human resources, quality management, and project management. A Lean Six Sigma Black Belt and Certified Lead Auditor in ISO 13485, Brian specializes in process improvement, HR, and regulatory compliance.

A veteran of the U.S. Navy, Brian honed his skills in managing large-scale projects, training, and quality systems. His experience includes leading quality remediation efforts, CAPA processes, and regulatory compliance strategies across multiple industries, including medical devices. He has a proven track record in building cross-functional teams and optimizing operations through Lean and Six Sigma methodologies.