Quality assurance

 

All Gynétics products are manufactured from latex free materials, suitable for human-assisted reproduction.

Assembled in a clean room, the products are subjected to stringent testing and the highest Quality assurance procedures conform CE directive 93/42/EEC. Gynétics is ISO 13485:2003 and ISO 9001:2008 certified and also complies to Quality System Regulation of the USA (FDA 21 CFR part 820) and to Medical Devices Regulation of Canada (SOR/98-282).

All products that are used to assist in the reproduction process are gamma or ETO sterilized.