Medical Device QMS Audit Services for FDA, ISO & MDSAP Compliance

Eliminating the “Request for Additional Information (AI)

Quality system audits are not just inspections — they are a direct measure of your organization’s operational maturity. Our medical device QMS audit services help companies prepare for, survive, and improve after audits conducted under FDA, ISO 13485, and MDSAP requirements.

Why QMS Audits Fail (Even When Companies Think They’re Ready)

Because auditors look for systemic evidence, not isolated documents: these areas are often overlooked: inconsistent procedures across department, weak CAPA effectiveness, poor risk-based thinking implementation, gaps between documented processes and actual practice and incomplete management review and supplier controls.

We provide independent, objective audits aligned with global regulatory expectations.

What Makes Our Audits Different:

Our audits are designed to improve systems — not just identify problems.

Auditor mindset informed by real inspection trends
Risk-based evaluation, not checklist auditing
Clear distinction between minor gaps and systemic risk
Practical remediation guidance your team can execute

We don’t just tell you what’s wrong — we help you fix it.

When to Engage QMS Audit Services:

Our clients typically engage us:

Prior to FDA, ISO, or MDSAP audits
After receiving audit findings or warning letters
During rapid company growth or restructuring
Before mergers, acquisitions, or investor due diligence
When internal audit programs need strengthening

Proactive audits dramatically reduce regulatory exposure.

Regulatory Planning

Early Concept Design & Development

Regulatory Strategy

QMS Implementation

Project Development & Precision Manufacturing

Supply Chain & Logistics

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Our Head Regulatory Consultant

First-Time Clearance

Strategic submissions that eliminate AI requests

Scalable QMS Architecture

Built for startups, ready for enterprise

Cutting Edge Design without the Stress

Got Questions?

FAQ:

What is the most common reason companies fail QMS audits?

Gaps between documented procedures and actual practice are the most common reason for audit findings. Auditors look for consistent, repeatable systems.

Do you help with audit remediation?

Yes. We provide clear, prioritized corrective actions and help ensure CAPAs address root causes, not just symptoms.

How is an internal audit different from a mock FDA audit?

Internal audits assess compliance, while mock FDA audits simulate how an inspector evaluates risk, evidence, and decision-making under real conditions.

Be audit-ready, reduce findings, and strengthen your quality system.