Quality Policy

Bio-Sensing Solutions S.L., operating under the DyCare brand, develops and delivers innovative health-tech software solutions to support healthcare professionals and patients throughout the rehabilitation journey. Our technology digitizes clinical workflows, enables remote monitoring, and tracks patient outcomes to empower evidence-based, personalized care.

To guarantee the safety, efficacy, and regulatory compliance of our products and services, DyCare’s Top Management commits to the following principles::

• Regulatory & QMS Compliance: Maintain, implement, and continuously improve a Quality Management System certified to EN ISO 13485:2016, ensuring full alignment with the EU Medical Device Regulation (MDR 2017/745) and all applicable national legislation for Software as a Medical Device (SaMD).
• Safety, Efficacy & Clinical Performance: Ensure all digital rehabilitation solutions are clinically validated, safe for intended use, and deliver measurable therapeutic value. Risk management (ISO 14971) and software lifecycle controls (IEC 62304) are embedded throughout development, verification, and post-market phases.
• Customer & Patient-Centricity: Understand and anticipate the needs of clinicians, patients, and partners. Actively collect feedback, monitor satisfaction metrics, and deliver timely, high-quality solutions that enhance rehabilitation adherence and outcomes.
• Innovation & Continuous Improvement: Drive technological advancement while maintaining rigorous quality oversight. Monitor quality objectives, performance indicators, and post-market surveillance data to implement corrective, preventive, and proactive improvements across products, processes, and personnel.
• People & Competence: Recognize that our team is the foundation of our success. Foster a culture of quality, ethics, and professional growth. Ensure all personnel receive role-appropriate training, understand their QMS responsibilities, and are empowered to contribute to organizational excellence.
• Information Security & Data Protection: While cybersecurity and data governance are managed under our standalone Information Security Policy, DyCare remains committed to applying secure-by-design principles, safeguarding patient health data, and ensuring system resilience in line with regulatory and clinical expectations.

Top Management will provide the necessary leadership, infrastructure, and resources to uphold this policy. It shall be communicated, understood, and applied at all organizational levels. This policy will be reviewed at planned intervals to ensure its continuing suitability, adequacy, and alignment with strategic and regulatory developments.