The manufacturing processes of MedLaser Family Ltd. are conducted in the framework of the ISO 13485 medical quality assurance standard, which guarantees a consistent and fully controlled manufacturing quality as well as the rapid and controlled elimination of any possible defect.
The devices manufactured by MedLaser Family Ltd. comply with the requirements specified in Council Directive 93/42/EEC concerning medical devices (the Medical Devices Directive).
Within the EU, medical devices cannot be marketed without the CE mark, as this mark indicates that the devices conform to the requirements specified in Council Directive 93/42/EEC concerning medical devices and can be freely marketed on the internal market of the European Economic Area (EEA). The annual accreditation of our company’s activities and products is done by EMKI-OGYÉI of code number 1011 [Medical Device Qualification and Hospital Engineering Directorate or the National Institute of Pharmacy and Nutrition], which is a notified body authorized for this task.
We put large emphasis on quality, thus every single device created is tested by an expert supervisor. MedLaser is manufacturing white-label products for Swiss and Japanese companies.
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