Audits

Eurofins Medical Device Consulting conducts different types of audits to address any gaps in quality system compliance.

Internal audits

Aim

• Internal audits aim to provide independent feedback that your organization's risk management, governance, and internal control processes operate effectively.
• It is beneficial for medical device companies to conduct unofficial internal audits prior to an official audit by a Regulatory Authority to ensure full compliance of quality and regulatory documentation.
• Internal Audits of the Quality Management System (QMS) are a requirement under ISO 13485.

Outsourcing
Internal audits are performed by either a company employee or by an external expert. A benefit of 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, report assessing compliance with the audited requirements.

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

• ISO 13485 – Quality System Manufacturing for Medical Device Manufacturing
• 21 CFR Part 820 – Quality System Regulation (QSR)
• MDSAP: Medical Device Single Audit Program
• ISO/IEC 27001 – Information Security Management System

External audits

• External audits are conducted by Regulatory Authorities
• In the European Union (EU), audits are conducted by Competent Authorities - an entity accredited by the EU Member State to act as a third-party assessor of manufacturers’ compliance with applicable 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.
• In the United States, audits are conducted by the U.S. Food & Drug Administration (“FDA”) Office of Inspection & Investigation (‘OII’).
• Eurofins Medical Device Consulting offers:
  • Preparations for external audit
  • 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. Our consultants can support all audit activities including handling corrective action activities related to audit findings (CAPA).