Audits

Eurofins Medical Device Consulting conducts different types of audits to ensure your regulatory compliance.

Internal audits

Aim

• Internal audits aim to provide independent assurance that an organisation’s risk management, governance, and internal control processes are operating effectively.
• Specifically, the purpose of the process is to assess the organisation and determine, based on assessment findings, whether the company has adequately followed the guidelines.
• It is beneficial for medical device companies to conduct unofficial internal audits prior to an official audit by a Notified Body or Registrar to ensure full compliance of quality and regulatory documentation.
• For ISO 13485, it is a compulsory requirement 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

• 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

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)