Audit for the medical device industry

Eurofins Healthcare Assurance auditors network helps you to identify and mitigate risks in your research and manufacturing sites, supply chain and distribution flows. Our auditors help you to ensure that you comply with international standards and market requirements recognized in the medical device industry.

The scope of Eurofins Healthcare Assurance audits covers:

Medical devices sites, suppliers and contract manufacturers based on international standards

• MDSAP
• ISO 13485
• 21 CFR 820

Sterilization processes

Distribution and post-market surveillance:

• GDP (Good Distribution Practice applied to Medical Devices): Distribution centers, Warehousing, Transportation
• GVP (Good Materiovigilance Practice): Service providers for Materiovigilance activities.
• GDPR
• ISO 9001

Auditing activities are compliant with EU, US, Canadian, Australian, Brazilian and Japanese regulations.