Quality

Regulatory Affairs

Compliance to global standards and regulations

Infus maintains compliance to international standards, regulations, as well as customer requirements.

We are ISO 13485, ISO 14001, and ISO 45001 certified by TUV SUD.

Both Infus facilities are US FDA registered.

Regulatory affairs at Infus

• FDA establishment registration and device listing

• Regulations, obligations, and reference standards compliance

• Product registration support

• Post market surveillance

Bangpoo Plant

Infus Bangpoo, our headquarters was founded in 1990

  • Located in Samutprakarn province
  • Only 35 km from downtown Bangkok and Suvarnabhumi International Airport
  • 15,000 sq.m of operational space

Khon Kaen Plant

Infus’ second facility was established in 2005 with the same technical capabilities, and is manged under the same quality management system

  • Located in Khon Kaen province, and education and business hub in the Northeast region of Thailand
  • 450 km from Bangkok, a 45 minute flight from Bangkok
  • 13,000 sq.m of operational space