Written by:
Alejandro Sánchez
RAQA Responsible
Date and signature: 28/02/2024 Firma Alejandro Sanchez
Reviewed by:
Miguel Uña
Compliance Director
Date and signature: 28/02/2024 Firma Miguel Uña
Approved by:
José Luis López Sánchez Pascuala
Date and signature: 28/02/2024 Firma José Luis López

Insulcloud, S.L. is a technology-based company specialized in the field of health, working in the design, development, manufacture and supply of R&D-based medical devices to improve the control and monitoring of the treatment of chronic diseases such as diabetes.

The company develops its activity considering innovation and development, quality as the main axes of its philosophy in its commitment to fulfill the objectives acquired since its foundation:

  • Improve the quality of life of patients with Diabetes.
  • Reduce costs to healthcare systems around the world.
  • To supply medical devices that meet the expectations, requirements and delivery times of its customers.

In order to achieve the highest level of competitiveness and customer satisfaction, the Management of Insulcloud S.L. hereby undertakesto:

  • Establish and maintain a Quality Management System to serve as a framework for setting and reviewing the company's quality objectives.
  • Comply with applicable regulatory requirements; in particular those pertaining to:
    • Regulation (EU) 2017/7745
    • Royal Decree 192/2023
    • UNE-EN ISO 13485:2018
    • 21 CFR 820
  • Comply with the requirements related to the Quality Management System, implemented according to the standard UNE-EN ISO 13485:2018.
  • Maintain the effectiveness of the Quality Management System.
  • To ensure that this Policy is applicable to the purpose of the organization through a systematic review of the QMS and quality objectives.
  • To ensure that this policy is communicated and understood within the organization at all levels.
  • To ensure that this policy is reviewed for its continuing suitability.
  • Assign, for each department, the necessary authority and responsibility for the correct development of activities and processes.
  • Provide the company with the necessary human and technical resources, adequate space and premises, suitable equipment and services, instructions and approved documents to ensure compliance with the defined requirements and objectives.