CORONIS RESEARCH S.A. is committed to excellence in delivering comprehensive services for clinical study design, clinical trial management, and medical device oversight to the pharmaceutical, biotechnology, and medical device sectors. The Company’s management has established its Quality Policy for Medical Devices in alignment with ISO 13485, prioritizing the safety and efficacy of medical devices and ensuring compliance with all applicable regulations and standards.
CORONIS RESEARCH S.A. undertakes a proactive approach to quality management, identifying and addressing potential risks and non-conformities throughout the lifecycle of medical devices. This approach facilitates the timely implementation of effective corrective and preventive actions to maintain the integrity of our services.
The primary Objectives of the Quality Management System are:
- To ensure the consistent delivery of safe and effective medical devices that meet regulatory and client-specific requirements.
- To enhance patient safety by minimizing risks associated with medical device development and use.
- To facilitate continuous improvement through regular reviews of quality objectives and performance metrics.
The Quality Management System is designed and implemented in such a way that:
- Quality requirements are systematically identified, documented, and evaluated to ensure compliance with ISO 13485.
- Effective risk management strategies are established to mitigate potential issues concerning medical devices.
- Comprehensive training and development opportunities are provided to employees, fostering a culture of quality and compliance.
The Company’s Management is committed to ensuring compliance with all legislative, regulatory, and industry requirements that govern its operations, thereby supporting the integrity and reliability of its services.
In pursuit of this commitment, the Company employs a structured methodology to identify applicable regulations and standards, along with rigorous processes to ensure ongoing compliance.
A fundamental commitment of the Company’s Management is the continuous enhancement of the Quality Management System’s performance.
The Quality Policy for Medical Devices is reviewed annually during management review to verify its effectiveness and relevance.
The Quality Policy for Medical Devices is accessible to all stakeholders interested in the Company’s commitment to quality.
To implement the Quality Policy for Medical Devices, CORONIS RESEARCH S.A. considers that active employee participation in adherence to, development of, and documentation of procedures under the Integrated Management System is necessary. The employees’ involvement is crucial for the effective implementation and ongoing enhancement of the Quality Management System, making compliance obligatory for the entire organization.