Quality
Infus implements a stringent quality system to fulfill customer requirements and compliance to international standards and regulations, ensuring product effectiveness and safety. We continually review and improve our quality system to ensure that our products are effective and safe for use.
We are certified and comply with:
• ISO 13485
• US QSR
• Thai GMP
• Japan GMP
Effective device configuration guarantees that every device is produced exactly according to customer specifications and comply to standards and regulation. Our device history records as well as our change control system ensures full traceability of our products.
Our quality system is improved continually, and assessed and certified through external audits. Infus' facilities are routinely audited by accredited certified body, customers, international authorities, and the US FDA with satisfactory conforming results.
Infus Bangpoo, our headquarters was founded in 1990
Infus’ second facility was established in 2005 with the same technical capabilities, and is manged under the same quality management system