Quality Policy

BETTER CARE, S.L. (hereinafter “Better Care”), is an organization dedicated to the design, development, manufacture, installation and servicing of medical device software for capturing and monitoring biomedical signals, providing data integration, centralization, recording and subsequent analysis for complex monitored patients.

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Better Care establishes, implements, and maintains a Quality Management System (QMS) in accordance with ISO 13485:2016, ensuring compliance with applicable regulatory requirements in all jurisdictions where its medical device software products are marketed.

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The QMS complies with the European regulatory framework, including Regulation (EU) 2017/745 on medical devices, as amended by Regulation (EU) 2023/607, and, where applicable, Directive 93/42/EEC, as well as the relevant national legislation such as RD 192/2023. For Canada and the United States, the QMS is certified under the Medical Device Single Audit Program (MDSAP), based on ISO 13485:2016, incorporates and demonstrates compliance with the regulatory requirements of participating authorities, including the Canadian Medical Devices Regulations (SOR/98-282) and applicable United States regulations under 21 CFR Parts 803, 806, 807, 820, 821, and 11.

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The Better Care Chief Executive Officer (CEO) ensures that quality and regulatory compliance are fully integrated into the organization’s strategic direction and decision-making processes.

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Vision

To become a trusted international reference in medical device software for biomedical data integration, supporting safer, more connected and data-driven clinical care

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Mission

To provide reliable and compliant medical device software that captures, integrates and centralises biomedical data, enabling healthcare professionals to make safer and more informed clinical decisions.

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Commitments

• Patient Safety and Product Performance: Ensure that products are safe, effective and perform as intended, maintaining the integrity and reliability of biomedical data.
• Customer Satisfaction: Maintain close collaboration with customers, understanding their needs and ensuring that expectations are consistently met.
• Risk Management (Risk-Based Approach): Apply a systematic risk management process to identify, evaluate, control and monitor risks associated with products and processes throughout their lifecycle..
• Process-Based Approach: Manage activities through defined, controlled and interrelated processes that ensure consistency, traceability and efficiency across the organisation.
• Continuous Improvement and QMS Effectiveness: Maintain and continuously improve the effectiveness and suitability of the Quality Management System, ensuring adaptation to evolving regulatory and technological requirements.
• Leadership: Top Management provides leadership, direction and resources to ensure the effectiveness of the QMS and the achievement of quality objectives.
• Evidence-Based Decision Making: We use the “feedback” information from our processes to guide us in the decisions that must be taken, always taking into account the stated objectives and the company's mission.
• People Engagement and Competence: Ensure personnel competence, training and awareness, promoting collaboration and accountability across the organisation.
• Mutually Beneficial Relationships: Maintain effective relationships with suppliers and partners to ensure compliance and enhance overall performance.
• Post-Market Surveillance: Monitor product performance and feedback in the field to ensure continued safety, performance and regulatory compliance.
• Information Security and Data Protection: Ensure the confidentiality, integrity and availability of data in accordance with applicable information security and data protection requirements.

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Better Care delivers high-quality medical device software that supports clinical decision-making while ensuring compliance, safety and continuous improvement across all operations.

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This Quality Policy is communicated, understood, implemented and maintained throughout the organisation, and made available to relevant interested parties as appropiate, and reviewed periodically to ensure its continued suitability and effectiveness within the Quality Management System.

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The Better Care Chief Executive Officer (CEO) ensures that this Quality Policy is implemented and the necessary resources are available to achieve the established quality objectives.

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Xavier García

Chief Executive Officer

BETTER CARE, S.L.