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Quality

All of Biohit’s products and processes from R&D to production and from marketing to sales comply with ISO 13485 quality standards, which cover the manufacture of medical device, and also with ISO 9001 and ISO 14001 quality and environmental standards. Biohit’s products are also CE/IVD (In Vitro Diagnostics) registered and approved.

Biohit manufactures almost all of its products itself, using clean rooms, demanding raw materials.
  • The Quality Management System of Biohit complies with the ISO 9001 and the ISO 13485
  • The Biohit Environmental Quality Management complies with the ISO 14001 Environmental standard.
  • Certified by Det Norske Veritas (DNV)