Hantech Medical Italy Successfully Passes BSI ISO 13485 Recertification Audit

We are delighted to share this great news with you.

Hantech Medical Italy has successfully passed the BSI ISO 13485 recertification audit.

Since first achieving certification in May 2025, Hantech Medical Italy has consistently adhered to ISO 13485 standards, embedding compliance and risk management into its daily operations. This recertification represents another important milestone in international quality compliance. It reflects the Italian team’s strong capabilities and disciplined approach in quality management, regulatory compliance, and risk control, while also demonstrating the ongoing enhancement of our global quality management system. This achievement would not have been possible without the close collaboration and efficient coordination between Hantech Medical's quality teams in China and Italy.

During the audit, BSI auditors recognized the standardization, completeness, and effectiveness of our quality management system, with particular commendation in the following five areas:

✅ Management and execution of investigations – including investigation processes, root cause analysis, and implementation of corrective actions
✅ Management and execution of validation activities – including the completeness of processes and results
✅ Maintenance and management of production process records
✅ Execution of process validation
✅ Management and execution of equipment calibration

Thank you to all colleagues who contributed to this achievement.

Let's continue striving for excellence.