Quality Policy

The quality policy of NEWMANBRAIN S.L. is aimed at ensuring that both the medical devices designed, manufactured and marketed meet the expectations of our customers and users, our contractual obligations, legal and regulatory requirements general and specific to our activity, and to ensure continuous improvement of processes and QMS.

 To achieve this objective, the company’s action strategy is based on the following principles and commitments:

• To guarantee excellence in the quality of performance in the products designed, manufactured and marketed.
• To understand and satisfy the needs and requirements of our customers.
• To understand and fulfill our contractual obligations.
• Maintain an effective Quality Management System.
• To ensure compliance with applicable Legal and Regulatory requirements.

The General Management assumes responsibility for defining, implementing and maintaining this Quality Policy, for which it has implemented a Quality Management System in accordance with the requirements of:

• Current standards EN ISO 13485:2016/A11:2021
• European Regulation EU 2017/745 on medical devices.
• Legislation in Spain, Royal Decree 192 of March 22, 2023, regulating medical devices.
• Requirements of the health authority AEMPS.

The effectiveness of the Quality Management System of NEWMANBRAIN S.L. depends on the unconditional support of all our employees, so that the staff makes the concern for Quality their own, understanding the importance of the task they perform and that the sum of all makes it possible to achieve the objectives.

The Quality Manager is under the direct supervision of the General Management in order to be totally independent from the other departments or persons involved in the production process. His/her access to the managerial spheres will allow him/her to suggest the implementation of as many procedures, revisions or corrective/preventive actions as he/she considers necessary for the implementation and maintenance of the Quality Management System.

The General Management ensures the dissemination of the Quality Policy in all areas of the Company, committing itself to ensure that it is understood, applied, reviewed and updated.

The General Management defines the specific objectives of the company and the key elements to achieve them as defined in its Quality Policy, assigning to each department the necessary authority and responsibility, making available the infrastructure and human, technical and economic resources to achieve the objectives.