Compliance support from every angle

In an industry where compliance is critical and the consequences of oversight can be severe, the audit process is more than just a regulatory requirement—it’s a vital safeguard. Whether you’re facing the complexity of ISO 13485 certification, preparing for a competent authority inspection, or managing your supplier oversight programme, the challenges are significant and the stakes are high. Navigating internal, external, and supplier audits demands time, technical expertise, and absolute rigour. 

At Eurofins Medical Device Consulting, we offer comprehensive audit support tailored to the realities of the medical device industry. From strategic internal audits that uncover gaps before regulators do, to full lifecycle support for regulatory authority inspections, our global experts can guide, prepare, and represent your organisation with precision. Our deep knowledge ensures that every aspect aligns with the latest regulatory expectations.

We offer internal audits to assess risk management, governance, and internal control processes, alongside support with QMS audits for ISO 13485 and 21 CFR Part 820. Full preparation and leadership for external audits within tight timelines. As well as supplier qualification audits, including annual and unannounced evaluations, and navigating compliance requirements for ISO 13485, 21 CFR Part 820, MDSAP, and ISO/IEC 27001.

Internal, External and Supplier's audits

Internal Audits

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Aim

  • Internal audits provide independent assurance that an organisation’s risk management, governance, and internal control processes are operating effectively
  • The process is designed to assess current practices and determine whether the organisation is operating in accordance with guidelines
  • For medical device companies, conducting informal internal audits before an official audit by a regulatory authority provides a vital opportunity to ensure full compliance of quality and regulatory documentation
  • Under ISO 13485, it is compulsory for a company to internally audit its Quality Management System (QMS)

Outsourcing

Internal audits are performed by either a company employee or by an external expert. The advantage of bringing in a third-party professional auditor is that the company will receive an objective review of the processes within its QMS.

Output

The output of an internal audit is a comprehensive, objective, bias-free report assessing compliance with the audited requirements.

The most common standards with which medical device companies need to comply are:

  • ISO 13485 – Medical devices — Quality management systems — Requirements for regulatory purposes
  • 21 CFR part 820 – Quality System Regulations (QSR)
  • MDSAP
  • ISO/IEC 27001 – Information technology – Security Techniques – Information security management systems 

External audits

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  • External audits are conducted by a Notified Body – an entity accredited by the Competent Authority of a European Union (EU) Member state to act as a third-party assessor of manufacturers’ compliance with applicable EU regulation for certain products prior to market entry.
  • Under specific regulations, Notified Bodies will perform conformity assessments based on the quality management system and assessment of the technical documentation, type examination, or product conformity verification.
  • Eurofins Medical Device Consulting offers:
  • Preparations for external audit within a limited timeframe.
  • Support with and leading of the external audit.
  • Documentation and support regarding deviations after the audit. 

Supplier’s audits and qualifications

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These are also required for the full qualification of suppliers and subcontractors (re-evaluation/annually). Our teams can assist you and conduct qualification, re-evaluation and unannounced audits. We can also help with audit report preparation and leading audits finding required activities (such as CAPA: Corrective Action/Preventive Action).