INSTRUCTIONS FOR USE (IFU)

IFU Document ID: G3-IFU-EN

IFU Version: 2.2

Date of issue: 3 September 2026

Device: Gosta AI Operating System (UDI-DI: 06429830288503)

Software Version: 4.X.X

Device Classification: Class I (self-certified, MDR 2017/745)

The Gosta AI Operating System is stand-alone medical software designed to support healthcare professionals in creating, reviewing, and managing clinical documentation and taxonomy based on spoken or transcribed encounters. The software uses artificial intelligence, including large language models, to:

The device is designed to improve efficiency, accuracy, and completeness of administrative and clinical record-keeping workflows within healthcare settings. By automating clinical documentation, the device improves the quality of patient-physician interactions while at the same time improving the completeness and quality of clinical documentation.

The device is not intended for clinical decision support or diagnostic use. All generated content must be validated by the healthcare professional prior to being added to the electronic health record (EHR/EMR).

The software is available through a web interface and a native mobile application.
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The Gosta AI Operating System is intended to:

It is intended solely for administrative documentation support and does not:

All note content must be reviewed and approved by qualified healthcare professionals before incorporation into patient records.

Intended Users

The device is not intended for patient self-use.
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Use Environment

The software indirectly supports all patient populations for whom professionals generate documentation. Therefore, it is intended for all indications.

Supported languages: English, Spanish, Portuguese, Dutch, Italian, French, Swedish, German, Finnish, Russian, Estonian, and Czech.

No contraindications are known.
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To begin a new session, the user selects New Encounter. The system verifies microphone signal strength and, depending on configuration, prompts for:

Recording begins when the user presses Start Recording.
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During or after recording, users initiate draft generation using the Create Note button. Processing comprises two stages:

Users may interrupt any stage by pressing Interrupt Processing.

Each draft note is divided into sections, which users may click to edit.

If the draft requires refinement, the user may select Regenerate, which opens a window allowing:

Once finalised, documentation is transferred manually:

A feedback interface appears after copying, prompting the user to rate the initial model output. Users are reminded not to include sensitive or personal data in free-text feedback.

Local copies of notes (stored in the browser session) can be deleted using the Delete icon next to the appointment. If notes are not manually deleted, they are automatically removed when the browser closes. Deleted notes cannot be restored, so users must ensure EMR transfer beforehand.

Gosta AI Operating System is a software-based medical device that requires a compatible end-user device and a functioning internet connection. Use of audio features additionally requires a functioning microphone.

The performance of the device may be affected by factors such as the end-user device, quality of the internet connection, operating environment, session duration, and the technical complexity of the language models used. Variations in performance, such as response times, may occur during use.
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To use the Gosta AI Operating System web application, the computer must run at least one of the following operating system versions:

No local software installation is required to use the web application.
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The web application is accessed using a supported web browser. The browser version must be at least:

Use of newer browser versions is recommended.
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Use of the mobile application requires a supported smartphone or tablet with a functioning internet connection. The mobile device must run at least one of the following operating system versions:

Use of audio features in the mobile application requires a functioning microphone and the necessary microphone permissions to be granted to the application.
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Users can authenticate and access the device through Single-Sign On, using their employer’s credentials, such as Azure-based authentication. When Single-Sign on is not available, users can authenticate and access with a unique username and password.
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The system is developed and operated according to ISO/IEC 27001-certified information security practices.
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General Safety Notes

Residual Risks

Despite established risk controls, including human review, risk of erroneous EMR entry cannot be completely eliminated.
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Warnings

All generated content must be reviewed for accuracy, completeness, and clinical correctness.

Safe use of the Gosta system requires that the user follows the instructions below regarding authentication and device protection.
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Authentication and password

Users must use a strong password when logging into the system. A strong password is recommended to be at least 15 characters long and to contain a combination of upper- and lowercase letters, numbers and special characters. The password must not be shared with anyone and must be kept confidential. Users should use a different password from other services, and they must change the password immediately if they suspect it has been compromised or disclosed to others.

Locking the workstation
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The Gosta Web application does not have an automatic session timeout, because patient appointments can be long and may include intentional pauses. It is the user's responsibility to lock the workstation whenever leaving it unattended, even briefly (Windows: Win+L, macOS: Ctrl+Cmd+Q), to keep a strong login password and an automatically locking screensaver enabled on the workstation, and to log out of Gosta at the end of the shift.
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Locking the mobile device

The Gosta Mobile application does not have a separate application-level lock, so protection of the mobile device relies on the operating system's device lock. It is the user's responsibility to keep a PIN, password or biometric authentication (fingerprint or face) enabled on the mobile device at all times. Without a device lock, the application cannot protect the data stored on the device. Notify the organisation's administrator and GostaLabs immediately if the mobile device is lost or compromised, so that the device pairing can be revoked from the server side.
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Import of disclosed information — prohibited

In accordance with the requirements applicable to social and healthcare services in Finland, processing of customer and patient information obtained on the basis of disclosure (luovutusperuste) requires authentication based on the social and healthcare professional certificate card (Sote-varmennekortti). Gosta does not currently support certificate-card authentication, and therefore importing disclosed information into Gosta is not permitted: users must not retrieve customer or patient information from another service provider's system (including the Kanta services) on the basis of disclosure and transfer it to Gosta. Both the service provider and the user are responsible for complying with this restriction.

9.1 Identifying an incident
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An incident means a malfunction, deterioration in performance, or incorrect output of the device that has led, or could have led, to harm to the health of a patient, user or other person.

For more information on identifying and reporting incidents: Fimea – Reporting of incidents
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9.2 Reporting an incident

Professional users must report all incidents related to the device both to the manufacturer and to the competent authority of the Member State.

As a cloud-based software solution:

No physical storage, cleaning, or disposal by users is required.

Gosta Labs Oy

Otakaari 5

02150 Espoo

Finland

Email: [email protected]

Chat support: available to logged-in users