Quality Policy
Insulcloud, S.L. is a technology-based company specialized in the healthcare field, working on the design, development, manufacturing and supply of medical devices based on R&D to improve the control and monitoring of treatment for chronic diseases such as diabetes.
The company conducts its activity considering innovation, development, and quality as the main pillars of its philosophy, in its commitment to meeting the objectives defined since its foundation:
- Improve the quality of life of patients with diabetes.
- Reduce healthcare system costs worldwide.
- Provide medical devices that meet customers’ expectations, requirements, and delivery deadlines.
In order to achieve maximum competitiveness and customer satisfaction, the Management of Insulcloud, S.L. undertakes, through this document, to:
- Establish and maintain a Quality Management System that serves as a framework for setting and reviewing the company’s quality objectives.
- Comply with applicable regulatory requirements, in particular:
- Regulation (EU) 2017/7745
- Royal Decree 192/2023
- UNE-EN ISO 13485:2018
- 21 CFR 820
- Comply with the requirements relating to the Quality Management System, implemented in accordance with the UNE-EN ISO 13485:2018.
- Maintain the effectiveness of the Quality Management System.
- Ensure that this Policy is applicable to the organization’s purpose through systematic review of the QMS and quality objectives.
- Ensure that this Policy is communicated and understood within the organization at all levels.
- Ensure that this Policy is reviewed for continuous suitability.
- Assign, to each department, the necessary authority and responsibility for the proper development of activities and processes.
- Provide the company with the necessary human and technical resources, adequate facilities and premises, appropriate equipment and services, approved instructions and documentation, to ensure compliance with the defined requirements and objectives.