At CibusMed, our mission is to develop, produce, and deliver high-quality medical devices and healthcare-related services that are safe, effective, and patient-centered. Our Quality Management System (QMS) is designed to meet the principles and requirements of ISO 15224:2016, ISO 13485:2016/A11:2021, ISO 9001:2015, ISO 14971:2019, and MDR 2017/745.

We are committed to maintaining an advanced, integrated QMS that promotes continuous improvement, risk-based thinking, and regulatory compliance throughout the life cycle of our devices and services.

 

Patient-Centered and Healthcare-Oriented Quality

CibusMed places the patient at the center of all activities. We are dedicated to delivering products and services that are:

• Safe and compliant with all applicable legislation and regulations
• Clinically effective, backed by evidence-based practices
• Accessible, timely, and equitable
• Delivered in a way that supports the psychological, physical, and social well-being of patients

We incorporate the eleven quality characteristics defined by ISO 15224:2016 into all processes to ensure safe, effective, and patient-centered healthcare delivery:

1. Appropriate and correct care – Ensuring that care is clinically justified and delivered in accordance with established standards and individual patient needs.
2. Availability – Guaranteeing that required products and services are accessible to patients without unnecessary limitations.
3. Continuity of care – Promoting seamless coordination across healthcare professionals and care settings to ensure consistent and coherent service delivery.
4. Effectiveness – Achieving desired health outcomes through the application of evidence-based practices, scientific knowledge, and ongoing performance evaluation.
5. Efficiency – Delivering care using optimal use of resources, including trained personnel, time, and infrastructure, to avoid waste and duplication.
6. Equity – Providing services fairly and without discrimination, ensuring equal access for all patient groups.
7. Evidence-/knowledge-based care – Basing decisions and practices on up-to-date scientific knowledge, clinical guidelines, and validated experience.
8. Patient-centered care – Respecting each patient’s dignity and individuality, including physical, psychological, social, and environmental needs as outlined in the International Classification of Functioning, Disability and Health (ICF).
9. Patient involvement – Actively involving patients in decisions about their care, acknowledging their preferences, and empowering them throughout the process.
10. Patient safety – Preventing harm through the systematic identification, assessment, and minimization of clinical and operational risks.
11. Timeliness and accessibility – Ensuring that care is delivered promptly and in the appropriate setting, without undue delay or barriers to access.

 

Our Quality Objectives

To support these principles, CibusMed establishes and monitors Key Performance Indicators (KPIs) and measurable objectives, including:

• Ensure patient safety and clinical effectiveness through risk-based product design and delivery
• Comply with MDR 2017/745 and all relevant standards
• Continuously improve customer satisfaction and accessibility
• Apply evidence-based practice and clinical appropriateness in nutritional and software solutions
• Maintain and improve QMS effectiveness and efficiency
• Invest in the competence and development of our personnel

 

Quality Is Everyone’s Responsibility

At CibusMed, quality is not limited to a department or person — it is a shared responsibility. We foster a culture where:

• All employees contribute to continuous improvement and regulatory compliance
• Clinical and business risks are proactively managed in accordance with ISO 15224 and ISO 14971
• State-of-the-art technologies are responsibly implemented
• Resources and infrastructure are adequately managed to ensure operational excellence

 

Leadership Commitment

Under the ultimate goal of maximizing patient benefit and customer trust, the management of CibusMed are fully committed to:

• Upholding the values of patient safety, clinical effectiveness, and service excellence
• Maintaining and improving the effectiveness of the QMS
• Supporting a culture of safety, transparency, and continual improvement

 

This policy is communicated, implemented, maintained, and reviewed regularly as part of the Management Review process to ensure its ongoing suitability, effectiveness, and alignment with our mission.

 

For CibusMed PC,

Panos Papandreou

Chief Executive Officer