Activity and PurposeISP-xr S.L. transforms healthcare through the use of cutting-edge technology that enhances care quality and optimizes clinical outcomes.Our innovative solutions enable healthcare professionals to provide personalized, effective, and safe treatments, improving patient experience and strengthening the medical community.We offer a range of solutions designed to:Improve patient care.Optimize clinical practices.Reduce costs and surgical times.
2. SolutionsISP-xr: A 3D surgical planning platform that allows surgeons and medical teams to create highly accurate and patient-specific anatomical models. It facilitates real-time collaboration between clinicians and biomedical engineers and integrates extended reality (XR) tools. It enhances decision-making, reduces surgical risks, and streamlines workflows.XR Simulation: Immersive environments for medical education that allow professionals to refine clinical skills and adapt to technological advancements in healthcare.AI-Support: A highly customizable artificial intelligence platform adaptable to multiple sectors. Each instance is trained around a specific objective, providing accurate and relevant recommendations based on user or patient needs.AI-Care: A video questionnaire system powered by AI that analyzes verbal consultations and improves patient understanding of medical instructions and treatment plans. It optimizes processes, reduces costs, enhances patient satisfaction, and integrates seamlessly with existing clinical management systems.These solutions represent the innovative core of ISP-xr S.L. and are continuously evolving to ensure stakeholder satisfaction, fostering a culture of ongoing improvement.
3. Quality Management SystemISP-xr S.L. has established and implemented a tailored medical device quality management system, based on the requirements of:UNE EN ISO 9001:2015UNE EN ISO 13485:2018This system ensures:Regulatory compliance across all business activities.Process efficiency and safety.Continuous and permanent improvement.Satisfaction of patients, professionals, and stakeholders.
4. MissionOur mission is to deliver value-added solutions that:Improve the lives of patients and society as a whole.Comply with SMART objectives (Specific, Measurable, Achievable, Realistic, and Time-bound).Facilitate personalized surgical planning that reduces costs and operating times.Are oriented toward clinical usability, reshaping the future of surgery and optimizing outcomes.
5. VisionPatient needs in healthcare are increasingly complex and demand specialized knowledge to provide effective solutions and strengthen the doctor-patient relationship.ISP-xr S.L. aims to be a strategic partner throughout the entire clinical lifecycle, developing tailored products that:Expand the limits of surgical knowledge.Improve current clinical outcomes and surgical interventions.Protect, validate, and deliver innovative solutions in the field of surgical planning.
6. ValuesThe core values guiding ISP-xr S.L. are:Quality: Excellence in products and services.Transparency: Clear and honest relationships with doctors, patients, and professionals.Leadership: Actively shaping a better future.Collaboration: Personalized orientation and joint solution development.Commitment: Full team alignment with corporate strategy.Knowledge: Strategic team of specialized experts.Excellence: Becoming an international benchmark in custom solutions.Efficiency: High integrity and qualified personnel.Innovation: Continuous evolution and development of new services.Respect: Commitment to eco-friendly and environmentally sustainable values.Equality: Open, transparent, and competitive recruitment policy, free from discrimination based on gender, disability, or ethnic origin.In addition, we focus on listening, observing, learning, and adapting to change, acting responsibly, efficiently, and with a global vision.
7. ConclusionTo apply this Medical Device Quality Policy, ISP-xr S.L. has implemented a robust and certified management system in compliance with ISO 9001:2015 and ISO 13485:2018 standards.Management ensures that:The policy is communicated and understood across the organization.It is reviewed periodically to align with regulatory changes and the needs of clients and patients.The necessary resources are allocated to guarantee its fulfillment.Through this commitment, ISP-xr S.L. reaffirms its dedication to innovation, safety, and continuous improvement in healthcare delivery.ISP-xr S.L.
Rev.00 – 03/04/2025