Quality Policy

Last updated: September 2, 2025.

1.- Purpose

The Trak Health Solutions S.L. (TRAK) Quality Policy reflects its commitment as a software-based medical device manufacturer (MDSW) and as a healthcare center authorized in the field of digital rehabilitation and data-driven personalized medicine.

This policy guides actions at all levels of the organization to ensure product and service excellence, patient safety, and continuous improvement of the Quality Management System (QMS).

TRAK is committed to meeting regulatory and customer requirements applicable to all phases of its products and services, in accordance with Regulation (EU) 2017/745 (MDR), ISO 13485, IEC 62304, the GDPR, and applicable national health legislation.

2.- Scope of application

This policy applies to all activities carried out by TRAK, both as a developer and manufacturer of MDSW, as a provider of healthcare services through its digital platform, and to clinical professionals. It applies to all hierarchical levels, including technical, healthcare, and management staff, and throughout all phases of the product and service lifecycle.

3.- Principles of action

Responsible leadership: Senior management promotes a culture of quality and provides the human, technological, and material resources necessary to meet strategic, technical, and regulatory objectives.
Customer and patient orientation: TRAK receives and analyzes the needs, expectations, and relevant data of its customers and patients in order to drive improvements in its products and services.
Process and risk-based approach: Strategic, key, and support processes are identified, managed, and controlled, with a preventive approach and systematic risk analysis.
MDSW Lifecycle Management: A secure development methodology is applied and compliant, ensuring traceability, verification, validation and secure transfer of each version of the product.
Regulatory and ethical compliance: Compliance with applicable regulations is guaranteed, including those on personal data protection (GDPR), medical device regulations, patient safety, and ethical requirements of the clinical environment.
Staff participation and competence: Continuous training of the human team is encouraged, promoting a culture of quality and individual responsibility.
Transparency and communication: Internal and external communication ensures the understanding and dissemination of the policy, values, and quality commitments within the organization and among customers and other stakeholders.
Continuous improvement: Mechanisms for review, evaluation and feedback of the QMS are established to detect opportunities for improvement in the safety, effectiveness and efficiency of the product and service.

4.- Quality Objectives

The quality objectives we aim to achieve through daily compliance and periodic updating of the quality policy guidelines are:

Ensure the safety, efficacy, and regulatory compliance of the medical devices developed.
Ensure traceability and change control throughout the entire product and service lifecycle.
Minimize software errors and optimize platform availability.
Improve response times in the provision of digital healthcare services.
Maintain and increase the satisfaction of our customers, patients, healthcare professionals, and other stakeholders.
Develop and maintain key competencies in healthcare technology, data protection, and regulatory compliance.
Strengthen post-marketing surveillance and feedback analysis as a tool for continuous improvement.
Promote a culture of quality and clinical safety in all units of the organization.

This Policy provides the framework for establishing measurable quality objectives. Specific objectives are defined and maintained in controlled and current documents, which are approved by senior management.