This section fulfils the EU MDR requirement for Instructions for Use (IFU) for software medical devices and is intended to be referenced from the Help Center.
Device Identification
Device Name: Noteless – AI Medical Scribe Platform
Medical Device Status: This software is a medical device.
ISO 15223-1 symbol: Medical device (MD)
Manufacturer: Noteless AS, Gaustadalléen 21, 0349 Oslo, Norway
Contact: [email protected]
Intended Purpose
The Noteless – AI Medical Scribe Platform is a reusable software device intended to assist healthcare professionals with clinical documentation by automatically transcribing and summarising patient consultations into structured medical notes.
Intended User and Use Environment
Intended user: Any healthcare professional.
Use environment: Professional healthcare settings (e.g., clinics, hospitals, private practice).
Version & Release
Current device version: 2.1.6
Date of release: 20 Oct 2025
UDI Carrier
UDI: Noteless - AI Medical Scribe Platform
UDI-DI: 506111166NOTELESS1403M6
UDI-PI: Version v2.1.6; Release data 2025-10-20
Warnings
Not a replacement for clinical judgment; human review is required.
Output quality depends on the clarity of the audio and accuracy of the transcription.
Do not rely on the software for diagnosis, monitoring, or patient management decisions without clinician verification.
Precautions
Clinicians must review and verify AI-generated notes before finalising or entering into the medical record.
Verify patient identifiers and clinical facts (e.g., medications, allergies, dosages, procedures) against source information.
Follow local policies for documentation, coding, and consent for audio recording (where applicable).
Maintain secure login practices; only authorised users should access patient data.
Compatible Equipment & Minimum Requirements
Microphones
Works with built-in laptop microphones and standard external microphones.
For best results, use a Noteless Microphone or high-quality headset mic; place minimum 10–20 cm from speaker; minimise background noise.
Recommended capture: 16 kHz sample rate or higher, mono.
Operating Systems & Browsers
Windows 10/11, macOS 12+, or latest stable Linux distributions.
Google Chrome, Microsoft Edge, Safari or Firefox current stable release.
Allow microphone permissions in the browser; keep OS and browser updated.
Hardware & Network
Modern CPU (released within last 5 years) and ≥ 8 GB RAM.
Stable internet connection ≥ 5 Mbps up / 10 Mbps down; latency < 150 ms recommended.
IFU Version Control
IFU version: 1.0
IFU date of issue: 20 Oct 2025
Serious Incident Reporting
Any serious incident must be reported to the manufacturer and the competent authority of the Member State in which the user is established.
Report to manufacturer: Noteless AS ([email protected])
Also report to: The competent authority for your Member State (e.g., national medical device authority).
Last updated: 20 Oct 2025
This IFU is provided digitally to avoid duplication with packaged leaflets and will be maintained in this Help Center section.