Quality management

CHIRANA Medical, Inc., and Chirana, Inc. as traditional producers of medical devices place great emphasis on producing safe, reliable and high-quality products, which at the same time meet the requirements of the customers.

We care about constantly improving our quality management system, which is based on the internationally applicable ISO standards.

The implemented quality management system meets the requirements of the European Medical Devices Directive 93/42/EEC and EN ISO 13485:2016.

The effectiveness and efficiency of the quality management system is regularly reviewed by the certifying body 3EC International a.s.. By obtaining and annually renewing this internationally recognized certificate, we prove to our customers and business partners the ability to produce safe and high quality products.

The certificates issued to companies CHIRANA Medical Inc. and Chirana, Inc.:

  • certificates attesting the compliance of the management system of the companies CHIRANA Medical, Inc. and Chirana, Inc. with the requirements of the ISO standard 13485:2016,

  • certificates attesting to compliance of the quality management system of the companies CHIRANA Medical, Inc. and Chirana, Inc. with the requirements of the European directive 93/42/EEC.

"Everything we do, we do for health."

EN - CE mark for anaesthesia and breathing units SK - CE mark for anaesthesia and breathing units EN - CE mark for dental units SK - CE mark for dental units EN - EN ISO 13485:2016 for TQM CHIRANA Inc. SK - EN ISO 13485:2016 for TQM CHIRANA Inc. EN - EN ISO 13485:2016 for TQM CHIRANA Medical Inc. SK - EN ISO 13485:2016 for TQM CHIRANA Medical Inc. EN - ISO 13485:2016 MDSAP for TQM of CHIRANA Medical Inc.