Audit & Compliance Services
MB&A deploys Qualera — an AI-native audit intelligence platform — on behalf of our clients. 100% document coverage. Methodology aligned with CP 7382.850 inspection procedures. Board-defensible outputs. You get the expertise of MB&A and the analytical power of Qualera. The client never needs to touch the platform.
>>When audit pressure hits, most teams scramble. MB&A steps in with the depth, perspective, and executorial 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 audit intelligence layer — powered by Qualera — streamlines execution, reduces prep time, and surfaces real risks before they surface in an inspection. Every finding comes with evidence, regulatory basis, and a complete audit trail your board and regulators can trust.
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.
QMSR Is Here. Your Audit Program Needs to Catch Up.
Internal audit reports are now FDA-inspectable under QMSR, effective February 2, 2026. CP 7382.850 demands cross-functional, risk-threaded evaluation across your entire quality system — simultaneously. No manual process catches that. No eQMS was designed for it. Qualera was.
Driven by curiosity and built on purpose, this is where bold thinking meets thoughtful execution. Let’s create something meaningful together.
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
Qualera-Powered Audit Services
Every engagement is delivered by MB&A's audit team, powered by Qualera's 25-agent intelligence platform. 100% document coverage. Human-in-command oversight.
Full Audit
MB&A plans and executes your internal or supplier audit end-to-end using Qualera. 100% coverage of SOPs, work instructions, and forms. Full report with findings, regulatory citations, and complete audit trail.
Draft Audit Report
Your team conducts the audit. MB&A delivers the AI-powered draft report — structured, cited, and ready for your review. You finalize and own the output.
Gap Assessment
Qualera maps your entire QMS against QMSR, ISO 13485, and CP 7382.850 inspection methodology. Prioritized gap report with remediation recommendations.
Internal Audit Retainer
Annual program — one full system audit plus quarterly process-area sweeps. Continuous compliance posture for companies that can't afford a surprise.
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