Medical Device Audit Support

Audits that drive value for medical device companies.

For start-ups and small companies navigating tight timelines and limited resources, audits are more than a requirement – they are an opportunity to strengthen your quality system and prepare for success. We provide onsite and remote audits for manufacturers, laboratories, and tissue establishments across the U.S., designed to be a critical risk control and improve quality.

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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 start by discussing your goals. We ask clarifying questions to understand why you need the audit so we can tailor our approach and deliver a truly useful product.

Plan

We prepare a custom audit plan to ensure compliance and meet your objectives. We provide a list of requested materials in advance to maximize efficiency on audit day.

Audit

Whether on-site or remote, we conduct a comprehensive review of documents and records. We ask focused questions to identify areas where your QMS can be strengthened, not just compliance gaps.

Report

You receive a draft report for your review before finalization. Our findings are clearly written to guide your team toward valuable corrective actions and meaningful process improvements

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Frequently Asked Questions

What is the timeline for an audit?

Most audits are completed within 2 to 4 weeks from initiation, but we understand that medical device companies, especially start-ups, sometimes have urgent needs, like audit preparation for regulatory inspections or submission deadlines. We can often accommodate urgent timelines and provide quicker turnaround. While we recommend scheduling in advance for best results, we will work with you to build a realistic timeline that meets your specific needs.

How much does it cost?

Audit pricing varies based on scope, sites, product complexity, and documentation readiness. We don’t publish standard rates because each engagement is customized. We are committed to transparent pricing and flexible structures, ensuring you get clarity, value, and high-impact results tailored to your specific goals and budget. 

Reach out for a quick conversation, and we’ll provide a clear estimate.

What regulations can you audit?

Our core expertise is in US FDA Quality System Regulation (21 CFR 820) and ISO 13485:2016, backed by over 15 years of experience in medical device quality systems. We help companies confidently navigate these requirements.

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 real value to your organization.

What happens after the audit?

After completing the audit, you’ll receive a detailed, professional report outlining findings, observations, and actionable recommendations. But our support doesn’t stop there. We provide hands-on assistance with the crucial next steps. This includes helping you develop or review corrective and preventive actions (CAPAs), performing effectiveness checks, and identifying practical process improvements. We offer guidance to ensure issues are not just addressed, but resolved in a way that measurably improves your long-term compliance and performance.
The audit is the first step; meaningful change happens next, and we are here to support you through it.

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