SmartHEN’s Quality Policy is aimed at ensuring that both the medical devices designed, manufactured, and marketed meet the expectations of our customers and users, our contractual obligations, and the general and specific legal and regulatory requirements applicable to our activity, as well as ensuring the continuous improvement of processes and the Quality Management System (QMS).

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

  • Guarantee excellence in the quality of the designed, manufactured, and marketed products.
  • Understand and satisfy the needs and requirements of our customers.
  • Understand and fulfill our contractual obligations.
  • Maintain an effective Quality Management System, allocating all resources deemed necessary to strengthen these foundations and achieve our objectives.
  • Ensure compliance with applicable legal and regulatory requirements.

General Management assumes responsibility for defining, implementing, and maintaining this Quality Policy. To this end, the company has implemented a Quality Management System in accordance with the requirements of:

  • The current EN ISO 13485 standard, “Quality Management Systems – Medical Devices”
  • Regulation (EU) 2017/745 on medical devices
  • Royal Decree 192/2023 on medical devices

Appropriate to the scope of the organization:

“Design, development, and manufacture of electromedical devices for enteral feeding”

The effectiveness of SmartHEN’s Quality Management System depends on the unconditional support of all our employees. Therefore, all personnel embrace responsibility for Quality, understanding the importance of their role and recognizing that the combined effort of all employees makes the achievement of objectives possible.

General Management ensures the dissemination of the Quality Policy throughout all areas of the Company, committing to ensuring that it is understood, applied, reviewed, and kept up to date.

General Management defines the company’s specific objectives and the key elements required to achieve them in accordance with its Quality Policy, assigning each department the necessary authority and responsibility, while providing the infrastructure and the human, technical, and financial resources required to achieve these objectives.