Modern Quality and Regulatory Solutions
The era of COVID forced us to look for new ways to manage Quality Systems and Regulatory Compliance.
MB&A now delivers audit intelligence powered by Qualera — an AI-native platform purpose-built for medical device quality systems. Every audit engagement leverages QAIRA, Qualera's orchestration engine, to deliver 100% document coverage with cross-functional reasoning and adversarial review. The result: audit findings that are comprehensive, defensible, and aligned with how FDA actually inspects under CP 7382.850 and QMSR.
Audit Intelligence That Goes Beyond the Checklist
Driven by curiosity and built on purpose, this is where bold thinking meets thoughtful execution. Let’s create something meaningful together.
Take your QMS management to the next level.
Our suite of tools and services are built to address the compliance challenges of today. Decrease costs, balance risk, and increase compliance with our cloud-based quality audit, supplier management, CAPA, and complaint monitoring tools and services.
Supplier Acceptance Rate
Cost of Supplier Quality Program
Cost of Internal Audit Programs
Third-Party
Audit Findings
Your compliance needs are unique; we curate solutions for a custom fit.
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Our audit team quickly and effectively assesses the risk present in any QMS and provides suggested remedies for gaps.
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We submit regulatory filings with bodies worldwide with few questions and fast approval.
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Our team brings calm to your crisis. Warning Letters, 483s, and field actions are just a process, and we know it well.
