Medical Devices Quality Policy

IERTEC SMART TECHNOLOGIES, S.L., hereafter IERTEC, is a company dedicated to

‘Design and development of electromedical devices and healthcare software for patient monitoring and support for health and social care’,

and, in accordance with UNE-EN-ISO 13485, declares that:

IERTEC's management will adopt, lead and promote quality as a priority objective of the company. Management therefore undertakes to provide the necessary resources envisaged to meet these quality objectives, as well as regulatory and customer requirements.

Continuous improvement across all the company's processes, products and services will be established as a key objective to achieve customer and employee satisfaction and, consequently, guarantee the company's future.

IERTEC's management expresses its commitment to the regulatory requirements applicable to the products with which it works. This management commitment will be further strengthened and assured through the implementation and maintenance of a Quality Management System integrated into the company in accordance with UNE-EN-ISO 13485. The ultimate objective is to ensure the safety and performance of the medical devices with which the company will work.

IERTEC's management will promote the process approach and risk-based thinking, ensuring that risks and opportunities that may affect product and service conformity and the ability to increase customer satisfaction are identified and considered.

To pursue our path towards excellence successfully, we identify our purpose within the market and society, the goals we hope to achieve and the values we must develop to achieve them.

IERTEC's Quality System will comply with the requirements of the UNE-EN-ISO 13485 standards, which will be certified by an accredited certification body. Maintaining this certification is considered a general objective.

Each year, IERTEC's management will establish measurable general objectives consistent with its strategy. Based on these objectives, and taking into account those affecting Quality, IERTEC's Quality department will develop them, analyse their achievement, and establish plans and resources to fulfil them.

IERTEC's Management will ensure that responsibilities and authorities within the organisation are defined and communicated.

IERTEC's Management will appoint the Quality Manager and delegate to them the authority to assess, recommend and initiate the actions needed to ensure that the Quality Management System conforms to UNE-EN-ISO 13485 and is implemented, maintained and continually improved.

This policy will be communicated to our employees and stakeholders to motivate their commitment to customers, the company itself and the quality of our services.

This policy will be continually adapted, updated and reviewed by IERTEC's management.

Guadalcacín, 19 January 2026

Jaime Oliva Pérez
CEO of IERTEC SMART TECHNOLOGIES, S.L.