ORTHOAPNEA’s management ensures that the quality policy:
  • It is appropriate to the purpose of the organization, through its annual review.
  • It includes a commitment to comply with the legislation applicable to ORTHOAPNEA’s products and services, to comply with UNE-EN ISO 13485:2016 and regulatory requirements and to maintain the effectiveness of the QMS.
  • Provides a framework for setting and reviewing quality objectives.
  • It is communicated and understood within the organization.
  • It is reviewed for continued suitability.

ORTHOAPNEA, trusts that the development of the Quality Management System and its proper use will become a valuable tool for the achievement of business objectives, as its premises should serve to increase our effectiveness, our efficiency and thus continuously improve, thus raising the degree of satisfaction of our customers.

Therefore, this Quality Policy will be linked to the evolution of our activities and the exercise of our functions, assuming that the optimal performance of the same must be promoted and procured thanks to the planning of the quality objectives and the execution of the actions programmed to achieve it, from these lines I commit myself to provide the resources foreseen for them and to monitor the progress of these plans, which will be communicated annually attached to this QUALITY POLICY, so that the entire organization is aware of them and collaborate to the extent of their possibilities and responsibilities.

OrthoApnea designs, manufactures, markets and distributes OrthoApnea devices and the elements necessary for their manufacture. OrthoApnea products are classified as Class I medical devices. These plans are reviewed annually by OrthoApnea management. The annual quality review evaluates the effectiveness of the system and the degree of customer satisfaction.