Quality Assurance

Rhinolight Ltd. deals with the manufacturing, installation, leasing and trading of the Rhinolight III, IV and the Skinolight phototherapeutic devices. The quality of the relating services have been achieved in accordance with customer and partner demands and official requirements. Rhinolight Ltd. is dedicated to continuously improve its quality assurance activity, and will comply the undertaken requirements with a constant pursuit of development.

The quality assurance system according to standards MSZ EN ISO 9001:2008 and MSZ EN ISO 13485:2003 were introduced, and the management and all the employees of the Company play a substantial role in the introduction and operation of this system. They are totally committed that the quality of our service would fully satisfy the expectation of customers, end-users, and the society. the society.

EC Certificate

ORKI (Insitute for Medical and Hospital Engineering), a Notified Body in Hungary, is an organization designated by the Minister of Health, in accordance with regulation 4/2009., with identification number EÜ01, and for the Council Directive 93/42/EEC with identification number 1011. Regulation no. 4/2009. EüM issued by the Minister of Health has regulations compatible with Council Directive 93/42/EEC on medical devices.

ORKI certifies that regarding the Rhinolight III and Rhinolight IV phototherapeutic medical devices Rhinolight Ltd. applies a quality system for the final inspection and testing which ensures that the products are manufactured in conformity with the technical documentation (referred to in annex VII and kept by the manufacturer). The EC Certificate has been issued in accordance with regulation 4/2009.