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Clinical and regulatory information

This document contains the essential clinical and regulatory information for the Doctomatic product, in accordance with the requirements of the ISO 13485 standard and the Regulation (EU) 2017/745 on medical devices.

4.5 Intended Use​

Doctomatic is a Medical Device Software (MDSW) intended for the collection and transmission of physiological data obtained from compatible medical devices, enabling patients and healthcare professionals to record routine non-invasive measurements and make this data available in a structured manner to support clinical follow-up by healthcare professionals.

5. Indications​

Doctomatic is indicated for the remote clinical follow-up of adult patients who require the periodic collection and review of physiological data to support continuity of care.

It is intended for situations where:

  • Healthcare professionals need structured data to monitor the patient's condition over time and identify relevant changes.
  • The remote collection of routine non-invasive physiological measurements and patient-reported information supports clinical follow-up without replacing in-person care or real-time monitoring.

6. Patient population and medical condition​

Patient population​

Doctomatic is intended for use in adult patients (≥ 18 years) undergoing remote or institutional clinical follow-up under the supervision of healthcare professionals. It is suitable for patients who require periodic monitoring of physiological parameters and whose clinical condition allows for non-acute, asynchronous follow-up.

Patients must be able to use the system safely, either independently or with caregiver support, as determined by the healthcare professional.

7. Medical condition​

Doctomatic is intended for the follow-up of chronic diseases or long-term health conditions that require regular observation of physiological data in non-acute settings. The system supports continuity of care by providing structured clinical information over time and does not replace clinical decision-making or emergency care.

8. Intended users​

Doctomatic is intended for use by patients and healthcare professionals, each with a defined role.

  • Patients: Patients use the Doctomatic web or mobile application to record and transmit physiological measurements and related information as part of their clinical follow-up, under the supervision of a healthcare professional.
  • Healthcare professionals: Healthcare professionals use Doctomatic to access and review physiological measurement data captured in a structured format. Doctomatic does not perform clinical interpretation or decision-making.

9. Intended use environment​

Doctomatic is intended to be used in non-acute settings for remote or distributed clinical follow-up, under the responsibility of healthcare professionals.

Patient use environment​

When used by patients, Doctomatic is intended for use in the home or similar non-clinical environments as part of a structured follow-up program. Patients use the system to record physiological measurements and related information in accordance with instructions provided by healthcare professionals. The system is not intended for use in emergency or time-critical situations and does not require continuous professional supervision during use.

Healthcare professional use environment​

When used by healthcare professionals, Doctomatic is intended for use in clinical, hospital or institutional settings, such as outpatient clinics, hospital wards, consultation rooms or similar healthcare environments. The system supports patient data review and clinical follow-up activities and is not intended for use in critical care or emergency settings.

In all intended environments, Doctomatic is used as a clinical follow-up support tool and does not replace professional judgment or in-person clinical assessment.

9 bis. Warnings​

  • Doctomatic is a clinical support tool and does not replace professional medical judgment. All clinical decisions must be made by qualified healthcare professionals based on their own assessment of the patient.
  • Doctomatic does not diagnose, treat or prevent diseases and does not provide automated clinical interpretation, diagnoses or therapeutic recommendations.
  • Doctomatic does not replace the medical devices used to measure physiological parameters. Only appropriate, properly calibrated and adequately maintained devices should be used.
  • The system depends on user-provided data. Incorrect use of measurement devices or inadequate data capture may result in inaccurate or incomplete information.
  • Doctomatic is not intended for emergency, critical or time-sensitive situations and does not provide real-time monitoring or alerts.
  • In case of sudden health deterioration, severe symptoms or emergency situations, users must immediately contact their healthcare professional or emergency services.
  • The system must be used within a clinical follow-up program and under the supervision of a healthcare professional.
  • Doctomatic does not generate diagnoses, clinical conclusions or autonomous decisions. All outputs are informational and intended solely to support clinical review.
  • Access to the system is restricted to authorized users. Sharing credentials or allowing unauthorized access is prohibited and may compromise data protection and traceability.
  • Doctomatic should not be used from unsecured or shared devices, as this may compromise the confidentiality of personal health data.
  • The system must be used in non-acute environments such as the home, clinical or hospital settings, and not in emergency or critical care environments.
  • Interruption of data capture or incomplete use of the system may result in data that is not suitable for clinical follow-up.
  • The system and any associated devices should not be used in environments with extreme temperatures, excessive humidity or exposure to liquids.
  • Doctomatic does not guarantee uninterrupted availability. Temporary unavailability does not constitute a medical emergency.
  • Any malfunction, technical issue or suspected incident related to the system must be reported to the manufacturer.
  • Personal health data processed by Doctomatic is protected in accordance with applicable data protection regulations and may only be accessed by authorized healthcare professionals.
  • Doctomatic must be used only for its intended purpose and in accordance with the provided instructions.

10. Contraindications​

The use of Doctomatic is subject to the clinical judgment of the healthcare professional and may not be appropriate in certain situations.

  • Doctomatic is contraindicated in emergency, acute or critical care situations that require continuous monitoring, immediate clinical intervention or real-time alarm systems.
  • Doctomatic must not be used as the sole source of information when the patient's condition requires in-person assessment or hospital supervision.
  • The use of Doctomatic may be contraindicated when the healthcare professional determines that remote follow-up is not clinically appropriate due to the patient's condition or care needs.
  • Doctomatic must not be used in patients who cannot safely operate the system or the associated measurement devices due to cognitive, physical or functional limitations, unless adequate caregiver support is available and the healthcare professional considers it appropriate.
  • Doctomatic must not be used for clinical scenarios that require the monitoring of parameters or clinical functions not supported by the system.
  • The system must not be used as a substitute for direct clinical observation, hospital alarm systems or specialized monitoring tools.

11. Adverse events​

To report any serious incident related to the product, please notify DOCTOMATIC S.L. and the competent authority of the Member State in which the user and/or the patient filing the report is established.