Medical device internal audits are essential to verify whether your quality management system works in practice and meets European regulatory expectations. Through structured audits aligned with ISO 13485, Sobel supports manufacturers in identifying risks early and preparing with confidence for notified body and regulatory inspections.
A structured audit helps organizations understand whether their quality system works in practice — not only on paper.
Medical device manufacturers in Europe are expected to demonstrate that their quality management system is documented, effectively implemented, and controlled in practice.
Internal audits are a key mechanism for identifying risks and non-conformities early, helping to reduce findings during notified body audits and regulatory inspections.
A structured internal audit also supports continuous improvement, strengthens regulatory readiness, and provides objective evidence of alignment with ISO 13485 and European regulatory expectations.
Sobel delivers a transparent and structured approach, conducted remotely or on-site according to your organization’s needs, with a strong focus on objective evidence, traceability, and clear documentation of findings.
Our materials characterization services are available in different modalities, depending on your medical device class and whether you need a new report, an update, or an expert technical review.
Recommended for manufacturers of lower-risk medical devices that require structured documentation of material-related information. This service results in a Material Characterization Report aligned with ISO 10993-1, supporting risk identification through the analysis of material composition, manufacturing processes, analytical methods (when applicable), stability considerations, physical characteristics, and cleaning validation.
Designed for higher-risk medical devices that demand a more robust technical foundation. This service provides a comprehensive Material Characterization Report aligned with ISO 10993-1, supporting the identification of material-related risks and ensuring consistency across complex device configurations and manufacturing processes.
Suitable when a Material Characterization Report has already been prepared and signed, but specific changes need to be addressed. This service focuses exclusively on updating the sections impacted by the change, while preserving all unaffected content, ensuring continuity and traceability without unnecessary rework.
Intended for manufacturers that have developed their own Material Characterization Report and require an independent expert review. Sobel critically evaluates the existing document and provides structured technical considerations, allowing your team to refine and adapt the report with greater confidence.
If you’re unsure which service applies, Sobel provides initial guidance to map the right route and ensure full compliance.
A robust internal audit process supports risk-based decision-making and demonstrates a proactive compliance culture. As part of a broader quality and regulatory strategy, Sobel offers additional services that complement internal audits, including:
We audit medical suppliers to ensure quality and GMP compliance.
Gap analysis, technical documentation, and ongoing regulatory for CE Mark for Medical Devices.
EAR for medical devices, supporting regulatory oversight and access to the EU market.
Medical device internal audits provide clarity, structure, and confidence in your quality management system. Sobel supports organizations with independent audits that deliver actionable insights and clear documentation, helping teams stay prepared for notified body interactions and European regulatory expectations.
1. What is the purpose of an internal audit for medical device manufacturers in Europe?
Internal audits verify whether the quality management system is effectively implemented and aligned with applicable standards, such as ISO 13485. In the European context, they also support preparedness for notified body audits and regulatory inspections by identifying gaps and risks early.
2. Are internal audits mandatory under European regulations?
Yes. ISO 13485 requires manufacturers to conduct internal audits at planned intervals. While the EU MDR does not prescribe how audits must be performed, notified bodies expect evidence of a robust and effective internal audit process as part of quality system assessments.
3. What is the difference between an internal audit and a notified body audit?
An internal audit is conducted by or on behalf of the organization to assess its own processes and compliance. A notified body audit is an external conformity assessment performed by a designated organization for certification or surveillance purposes. Internal audits help organizations prepare for notified body audits and reduce the risk of findings.
4. Can internal audits be conducted remotely in Europe?
Yes. Remote internal audits are widely accepted in Europe when appropriately planned and executed. The audit format (remote or on-site) should be defined based on scope, risk, and organizational needs, while ensuring access to objective evidence and effective interaction with relevant personnel.
5. Which standards can be covered during an internal audit?
Internal audits are commonly aligned with ISO 13485, but the scope may also include related quality system procedures, EU MDR requirements, and internal policies, depending on the organization’s regulatory strategy and audit objectives.
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