Mavera Medical Devices Inc. guarantees that the products are designed, manufactured and packaged on application of the EN ISO 13485 certified quality management with all possible care, using the most suitable state-of-the-art processes and applying the principle of integrating safety into its design and manufacture.

This system is designed to guarantee the safe use of device when it is employed under condition and for the purposes for which it is intended, in accordance with precautions described in the operator’s manual and/or instructions for use and to minimize the risks associated with the use of the device as far as possible, although they cannot be totally eliminated. The device must only be used under the responsibility of specialist medical personnel, taking account of the unavoidable risks and the possible side effects and complications of the treatment for which, it is designed, including those referred to in other sections of these instructions for use.