A reliable supply chain is fundamental for medical device compliance. Rely on our medical device supplier audit services to verify whether your partners meet the quality, documentation, and process requirements necessary for safe and compliant manufacturing.
From document control to process verification, our approach gives you clarity, risk reduction, and confidence in your supplier relationships.
Supplier performance directly impacts product safety, manufacturing quality, and regulatory outcomes.
Independent verification helps identify gaps early, preventing nonconformities during audits or inspections.
A structured supplier audit or qualification process reduces operational risk and strengthens your overall Quality Management System.
Whether you need to evaluate a new supplier or verify ongoing conformity, Sobel provides structured, expert-led solutions for supplier audits and supplier qualification.
Depending on your company’s objectives and supplier risk level, you can request a medical device supplier audit, a supplier qualification, or a complete audit + qualification package.
Best for companies needing a structured, independent evaluation based on applicable standards. The audit reviews document and record control, service provision, product and process verification, and the supplier’s own qualification process. Conducted remotely.
Ideal when you need to formally qualify suppliers according to your company’s quality standards. This service evaluates documentation and compliance criteria provided by the supplier and results in a supplier qualification report.
Recommended for manufacturers seeking comprehensive supplier assurance. This combined approach includes a full supplier audit plus a formal qualification review, offering complete visibility into documentation, processes, conformity, and supplier reliability—ideal for critical suppliers or high-risk categories.
Our supplier auditing and qualification approach is built around clarity, objectivity, and traceability. Trust a team with proven experience in supplier compliance and regulatory expectations.
We evaluate your suppliers against applicable standards and your quality expectations, providing actionable insights to strengthen compliance and ensure reliable partnerships. In addition, you can benefit from the following related services:
Expert-led training programs that strengthen risk management and compliance.
Support for CEP and CER development, including strategic planning, literature reviews and more.
With Sobel’s medical device supplier audit and qualification services, you gain independent, structured evaluations that reduce risk, improve quality, and support regulatory readiness. Our expert approach ensures your supply chain works in alignment with regulatory expectations—strengthening both your QMS and your long-term compliance strategy.
1. What is a medical device supplier audit and why is it required in the U.S.?
A medical device supplier audit is an independent evaluation of a supplier’s processes, documentation, and controls to ensure compliance with FDA 21 CFR 820 requirements. FDA expects manufacturers to demonstrate oversight of their suppliers, making supplier audits a key element of QMS compliance.
2. Does the FDA require supplier qualification?
Yes. FDA expects manufacturers to assess, select, and periodically re-evaluate suppliers based on their ability to consistently meet quality, safety, and regulatory expectations. Supplier qualification is documented evidence that the supplier is fit for use.
3. Can a remote supplier audit meet FDA expectations?
Yes. Remote audits are acceptable when they adequately review procedures, records, and implementation evidence. FDA’s focus is on the quality and depth of the assessment, not the physical location of the audit.
4. How often should manufacturers conduct supplier audits?
Frequency depends on supplier risk level, regulatory requirements, and internal QMS policies. Critical suppliers may require annual audits, while lower-risk suppliers may be reviewed on a longer cycle or qualified through document-based assessments.
5. What is the difference between a supplier audit and supplier qualification?
A supplier audit reviews processes and implementation in detail, while supplier qualification focuses on confirming that the supplier meets your organization’s documented quality requirements. Many companies use both together for high-risk or strategic suppliers.
6. Does Sobel help companies choose between a supplier audit and supplier qualification?
Yes. We assess supplier risk, regulatory requirements, and your QMS structure to recommend whether a medical device supplier audit, a qualification process, or a combined approach is appropriate.
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