QUALITY AND SAFETY POLICY OF QUBIOTECH HEALTH INTELLIGENCE, S.L.

Qubiotech Health Intelligence S.L. Is a company whose mission is to develop innovative products that convert advanced research into medical imaging into useful tools that facilitate daily clinical practice. The company is aware that its products must ensure the highest requirements of reliability and safety in its operation, so it is fully committed to the research and maintenance of quality management systems and safety to help us provide the customer reliable and safe products.

Our Quality Management system complies with the requirements of the international standard ISO 13485, referring to the Quality Management system applicable to medical devices and allows the CE marking of our products according to the most demanding standards. For this reason, the Management of Qubiotech Health Intelligence shows its commitment to quality through this Quality Policy, and undertakes to disseminate it to all levels of the company, and to provide the necessary resources to fulfill the following objectives:

  • Maintain the Quality Management System, based on the standard UNE-EN ISO 13485: 2012, adjusted to the needs of the company at all times, seeking the effectiveness and the efficiency of the processes.
  • Provide the company with the necessary human and technical resources to ensure quality in the delivery of products and services offered.
  • Create a favorable climate by training and motivating staff in relation to quality and teamwork, enabling professional and personal development of all staff members and achieving the required quality.
  • Prevent nonconformities, anticipating the appearance of the same, always giving a fast and favorable response to any damage caused to the customer.
  • Periodic review by the Management of the Quality Management System as a basis for continuous improvement.
  • Adoption of all necessary measures to ensure compliance with all applicable regulations as well as the requirements of the Customers and those of the company itself.
  • Comply with all laws, regulations, standards of the country in which our products are marketed.

For this reason, Management undertakes that all departments of the organization contribute, to the extent that it corresponds to them, to the compliance with the established Quality Policy.

In addition, Qubiotech Health Intelligence is fully aware of the importance and sensitivity of the information introduced in its web platform to obtain information of clinical value. The procedures of design and development of our products incorporate the evaluation of safety risks from the very conception of the product, applying the philosophy Safe by design.

Thus, our products have the appropriate technical measures to ensure the integrity and security of the data provided by customers. Therefore, all medical images uploaded to Qubiotech's image processing and quantification platform are anonymized during upload, destroying the original files, and processing only anonymous images to deliver the results to the client. These procedures ensure that Qubiotech products comply strictly with the provisions stipulated in LOPD and EU Directive 2016/679.

Signed. Daniel Fernández Mosquera, PhD

Managing director of Qubiotech Health Intelligence, S.L.