Audit Hosting & Execution
Expert-Led Audits. No Extra Headcount. No Surprises.
>When audit pressure hits, most teams scramble. MB&A steps in with the depth, perspective, and executional strength you need to get ahead of it.
We don't just help you pass audits. We help you own them.
We Lead the Critical Functions
That Keep Your Projects Moving
Strategic Audit Execution
Whether you're facing a scheduled inspection or getting ahead of overdue site audits, we lead audit hosting and execution with speed, credibility, and real-world industry insight.
You don't need to expand your internal headcount or overburden your team. Our experts embed into your process, bring immediate structure, and deliver exactly what auditors are looking for, without wasting time on checks that don't add value.
Explore Our Approach
Why Teams Turn to MB&A
Industry expertise meets operational excellence. Here's what sets us apart.
Seasoned Expertise, When You Need It Most
Even organizations with established audit teams can face capacity gaps or complex challenges that call for additional support. Our team brings seasoned audit expertise when and where you need it most so critical projects stay on track without disruption.
Industry-Aware, Risk-Focused
Because we've been in your shoes and across the table from FDA and Notified Bodies, we know what's coming and how to prepare. We prioritize high-risk areas strategically.
Tools that Optimize. Insights that Matter.
Our proprietary audit tools streamline execution, reduce prep time, and help you surface real risks, not just generate paper trails.
Designed for Modern MedTech
With today's regulatory scrutiny and global supplier complexity, reactive audits aren't enough. We help you identify issues early and build trust with regulators.
Catching Up Has Never Been Easier
You're not alone. We've heard this from more leaders than we can count.
"My sites haven't been audited by FDA since before COVID."
Whether you're catching up after years of delay or responding to an urgent customer request, we provide the clarity, coverage, and credibility to guide you through it. Fast.
— A common challenge we hear from quality leaders across the MedTech industry
What We Deliver
Four core services designed to strengthen your audit capabilities and regulatory readiness.
Audit Hosting & Execution
Internal and supplier audits managed from planning to reporting with strategic oversight and execution expertise you can count on.
Gap Assessments
Focused reviews aligned to FDA, ISO 13485, and EU MDR expectations to identify compliance opportunities before inspections.
Audit Readiness Support
Ensure your QMS, documentation, and team are thoroughly prepared to respond effectively to regulatory scrutiny.
Post-Audit Remediation Planning
Targeted action plans that address root causes and close findings efficiently while strengthening your systems long-term.
We're Making Audit Execution a Strength, Not a Stressor
The right partner makes all the difference
You Don’t Need More People. You Need the Right Partner.
Contact us today to talk about how MB&A can help you scale your quality oversight without scaling your team.
Contact Us Today