Quality & safety 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.

The Quality Management System covers the activities of:

Manufacture of medical devices for medical diagnosis which:

  • process cardiac electrical signals and their associated clinical variables;
  • allow the display and labeling of cardiac electrical signals;
  • detect cardiac arrhythmias and electrocardiographic patterns".

The scope of the Security and Privacy Management System includes:

Information systems underpinning cardiology services for remote diagnosis and monitoring, including their development, maintenance and support.

The purpose of the Integrated Management System is the satisfaction of the clients of IDOVEN 1903 S.L., the fulfillment of all the requirements, both those specified by the client and the legal or regulatory ones, and those necessary for the correct functioning of the organization.

To this end, the management of IDOVEN 1903 S.L. undertakes to fulfill the following general objectives:

  • Commitment to comply with applicable legal requirements, in addition to complying with customer requirements and with the requirements of the Integrated Management System implemented, based on the reference standards.
  • Formally manage information security and privacy, based on risk analysis processes, to reduce or eliminate the risks inherent in our activities by continuously improving the security performance of our processes, products and services.
  • Commitment to promoting the maintenance and improvement of the Integrated Management System implemented, bringing into play all the resources it deems necessary to strengthen these bases and the achievement of our objectives.
  • Commitment to effective control of all our activities, with an emphasis on quality, information security and privacy of our products and services, customer service and customer satisfaction.
  • Commitment to promoting an understanding and dissemination of our Quality, Information Security and Privacy Policy within our organization, through training and continuous communication with our employees.