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.
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