Mondragon

Mondragon, Spain

A 27,000 sq. ft (2,500 sq. m) site and headquarters for the Medical IVD Business Unit. This site specializes in New Product Development and Manufacturing.

Services

  • Bio assay transfer to automated microfluidic systems
  • Microfluidic cartridge development
  • System to consumable interface development
  • Microfluidic cartridge Transfer to manufacturing
  • Microfluidic cartridge high volume manufacturing

Contact

Goiru Kalea, 9

20500 Arrasate

Gipuzkoa

Spain

+34 943 84 68 37

Contact and Certifications

  • ISO 13485 standards
  • MDR (EU) 2017/745,
  • USFDA Regulation 21 CFR 820
  • ISO 5
  • ISO 7 and 8 according to ISO 144644

 

Click here to download our certifications.