Hydrosun Medizintechnik GmbH has established a Quality management system and an audit has given evidence that the quality system is in compliance with the requirements of DIN EN ISO 13485.

It fulfills the requirements according to Annex II, section 3, Medical Devices Directive 93/42/EEC.

   
pdfISO-13485_2016-certificate_en_de.pdf  
pdfEC-Certificate_en_de.pdf