We've Lived the Audit. Now We Lead Through It.
From QMSR readiness to remediation and beyond — MB&A brings hands-on regulatory expertise to every engagement.
Readiness Success
Supported to Market
Industry Experience
from Existing Clients
Audit & Compliance Services
We lead essential functions, keeping your projects on track without expanding internal headcount.
Regulatory Affairs
Launch confidently in global markets with strategic support for FDA, EU MDR, and more including audit readiness.
Audit Intelligence
We help you integrate AI/ML into your operations, turning complex data into actionable insights and competitive advantage.
Reshoring
We guide your reshoring initiatives to improve supply chain control, reduce lead times, and mitigate risk.
Project Management
We lead cross-functional teams with precision—driving timelines, budgets, and quality outcomes across the finish line.
Staffing & Recruitment
We place experienced professionals in quality, regulatory, and operations role to match your team’s culture and goals.
Quality Systems Management
From implementation to remediation, we build scalable QMS solutions that meet global regulatory standards.
Strategic Sourcing
We maximize supplier value with strategic sourcing support that ensures quality, cost-efficiency, and reliability.
Why Partner with MB&A?
Choosing the right partner makes all the difference.
Here's why leading medical device companies trust MB&A:
We've Been Where You Are
We understand your unique pressures and priorities, having personally navigated regulatory complexities and operational challenges in the medical device industry.
Actionable Solutions, Not Just Advice
Unlike traditional consulting firms, we actively collaborate with your team, providing hands-on support to implement sustainable solutions.
Customized, Practical Approach
Every client receives tailored strategies designed specifically around their needs, goals, and operational realities.
Integrity & Accountability
Your business is our priority. We approach every project with integrity, genuine care, and full accountability for outcomes.
We're not just consultants, we're your strategic partner, committed to your personal and professional success.
What Our Clients Say
Tom Williams, Millstone Medical
— Tom Williams, Millstone MedicalNo matter your specific needs in the medical device field, the MB&A team is an undeniably strong partner. They possess the expertise, dedication, and unwavering commitment to support your unique goals. I highly recommend them!
— Dan Kahn, General Manager, hg medical USA, LLCMy experience with MB&A was exceptional. Their team demonstrated the highest level of professionalism and provided invaluable support. Their consistent communication, attention to detail, and commitment to excellence made a significant difference.
— Alissa Calaway, RN, MSN, Director of US Clinical Affairs, ulrich medical USAWe engaged MB&A to prepare for a routine FDA surveillance inspection. They identified critical gaps in our CAPA system and document control that our internal team had missed for months. We passed with zero 483 observations.
After receiving a warning letter, we needed a partner who could lead remediation without disrupting production. MB&A embedded with our team, rebuilt our complaint handling process, and helped us close out every commitment ahead of schedule.
As a startup with no quality infrastructure, MB&A designed our entire QMS from scratch — document control, design controls, risk management, supplier quality — all audit-ready from day one.
