Quality & Security Policy

IDOVEN 1903 S.L. has implemented and maintains an Integrated Management System for Quality, Information Security and Privacy, based on the requirements of the following standards ISO 13485 "Medical Devices - Quality Management Systems" and the European Regulation on Medical Devices, relating to Medical Devices, Medical Devices and Medical Devices. MDR 2017/745 on medical devices, ISO 27001, ISO 27017, ISO 27018, ISO 27701 and the Royal Decree 3/2010 regulating the National Security Scheme.

Quality Management System (Scope)
Manufacturing of medical devices for clinical decision-making support that:

  • Process electrical heart activity signal and its associated clinical variables.
  • Allow the visualization and labelling of electrical heart activity signals.
  • highlight the cardiac arrhythmia and electrocardiographic patterns.

Security and Privacy Management System (scope)
Information systems supporting cardiology services for remote clinical decision making including their:

  • Development
  • Maintenance
  • Support

Quality and Security Policy

At IDOVEN 1903 S.L, we are committed to providing safe and effective products and services that meet or exceed our customer expectations through:

  • Maintaining a business environment, culture, and structure in which Quality, Compliance and Customer Focus are the highest priorities.
  • Ensuring compliance that meets ISO 13485:2016, the U.S. Food and Drug Administration’s Quality Management System Regulation 21 CFR 820, the EU Medical Device Regulation 2017/745, ISO 27001 and all other applicable governmental regulations.
  • Developing innovative state of the art designs while continuously improving our products and services.
  • Guaranteeing the continued effectiveness of the Quality Management System through regular assessment and process improvements.
  • Safeguarding all information security and privacy.