Medical Device Audit Support

Onsite and remote audits for manufacturers, laboratories, and tissue establishments across the U.S.

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We Offer

Supplier & Vendor Audits

Prevent problems before they become your problem.
Supplier and vendor audits help you detect issues before they lead to rework, complaints, recalls, or regulatory action.

Whether you’re outsourcing manufacturing, sterilization, or lab testing, supplier audits verify that your partners meet your standards.

    • ISO 13485 and 21 CFR 820 audits
    • Audits of contract manufacturer, sterilizer, & components
    • Biocompatibility and GLP lab audits (21 CFR 58)
    • Audits of tissue suppliers (ISO 20387, 21 CFR 1271)

Internal Audits

Internal audits aren’t just a checkbox – they’re a critical risk control.
A robust internal audit program improves quality, reduces cost, and ensures compliance with regulatory requirements.

Qualomics provides independent internal audits for:

    • ISO 13485 and FDA QSR (21 CFR 820)
    • Risk management processes (ISO 14971)
    • Nonclinical testing oversight (21 CFR 58 / GLP)
    • Tissue establishment compliance (ISO 20387, 21 CFR 1271)

GLP Lab Audits

For preclinical laboratories supporting FDA submissions

Contract research organizations (CROs) conducting nonclinical studies must comply with FDA’s Good Laboratory Practice (GLP) regulations under 21 CFR Part 58. Audits help verify that documentation, quality systems, and study controls meet submission standards.

    • GLP audits for biocompatibility and toxicology labs

    • Sponsor-side audits of CROs performing nonclinical studies

    • Compliance support for FDA submission readiness

Tissue Banks and Suppliers

For biobanks, tissue establishments, and processors

Tissue-based materials used in regulated products are subject to strict requirements for donor screening, traceability, and storage. Audits support compliance with applicable quality and regulatory frameworks.

    • Internal audits for tissue banks and establishments

    • Supplier/vendor audits of tissue processors and storage partners

    • Compliance assessments for ISO 20387 and 21 CFR 1271

Our Process

Quote

We ask a series of questions to help us understand your goals. Audits may be conducted for a variety of reasons and our goal is to give you a useful product.

Plan

We prepare a custom audit plan to ensure the audit is compliant and meets your goals. We send a list of requested materials before the audit to make audit day more efficient.

Audit

Whether on-site or remote, we start with a review of documents, followed by a review of records. We ask clarifying questions as we seek out areas of the QMS that should be strengthened.

Report

You will receive a draft audit report for review before sending the final version for signature. Findings are written to point your quality team towards valuable corrective actions.

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Frequently Asked Questions

What is the timeline for an audit?

Most audits can be completed within 2 to 4 weeks from project initiation, depending on scope and availability. In some cases, we can accommodate urgent timelines and complete an audit with quicker turn-around.

To ensure the best results, we recommend scheduling audits in advance—especially if you’re preparing for a regulatory submission, inspection, or supplier onboarding. Early scheduling allows time for proper planning, document review, and coordination with your internal or external teams.

We’ll work with you to build a realistic timeline that meets your needs without sacrificing quality or thoroughness.

How much does it cost?

Audit pricing depends on several factors, including the scope of the audit, number of sites or suppliers involved, product complexity, and documentation readiness. Because each engagement is customized, we don’t publish standard rates.

That said, our clients consistently tell us they appreciate the clarity, value, and expertise we bring. Whether you’re looking for a one-time audit or ongoing support, we offer transparent pricing, flexible structures, and high-impact results tailored to your needs.

Reach out for a quick conversation and we’ll provide a clear estimate based on your specific goals.

What regulations can you audit?

US FDA Quality System Regulation (21 CFR 820) and ISO 13485:2016 are the foundation of our auditing services. With 15+ years of experience in medical device quality systems, we specialize in helping companies navigate these core requirements with confidence.

In addition to QSR and ISO 13485, we audit to a range of regulations that often apply to devices, diagnostics, and biologics, including:

    • ISO 14971 – Application of risk management to medical devices

    • 21 CFR Part 58 – Good Laboratory Practice (GLP) for nonclinical studies

    • 21 CFR Part 1271 – Regulations for human cells, tissues, and cellular/tissue-based products (HCT/Ps)

    • ISO 20387 – General requirements for biobanking

    • Supplier and contract partner evaluations – Including audits of CMOs, sterilization providers, CROs, and tissue processors

Whether you need internal audit support, third-party supplier assessments, or help preparing for regulatory inspections, our audits are designed to add value.

What happens after the audit?

After the audit is complete, you’ll receive a detailed, professional report that outlines findings, observations, and actionable recommendations. But the support doesn’t stop there.

We can assist with next steps, including developing or reviewing corrective and preventive actions (CAPAs), performing effectiveness checks, and identifying practical process improvements to strengthen your quality system. Whether you’re responding to internal findings or preparing for an external inspection, we offer guidance to help ensure issues are not only addressed, but resolved in a way that improves long-term compliance and performance.

The audit is the first step. What follows is where meaningful change happens, and we’re here to support you through it.

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