Promotional Materials

Purpose

This section showcases promotional materials for Legit.Health Plus, our CE-marked Class IIb medical device certified under MDR 2017/745. These materials have been prepared for certification requirements and to demonstrate compliance with Notified Body BSI (2797) audit standards.

These promotional materials serve two critical functions:

1. Regulatory Compliance: Meeting MDR 2017/745 requirements for promotional material documentation prior to certification
2. Market Communication: Showcasing our achievement of CE marking and the advanced capabilities of our AI-powered dermatology diagnostic device

Promotional Flyer

The following promotional flyer is designed for distribution at medical conferences, trade shows, and healthcare facilities.

Legit.Health Plus

AI-Powered Diagnosis Support for Dermatology

CE Marked Medical Device

Class IIb Medical Device | Notified Body: BSI (2797)

Capabilities

239

ICD-11 Categories

Comprehensive diagnostic coverage

99.7%

Accuracy Rate

Clinical validation proven

5 sec

Processing Time

Instant results via API

FHIR

HL7 Compatible

Seamless EHR integration

Clinical Excellence

• Advanced Severity Scoring

  SCORAD, IHS4, AUAS, and more clinical scoring systems

• Vision Transformer Technology

  State-of-the-art deep learning architecture

• Image Quality Assessment (DIQA)

  Ensures optimal diagnostic accuracy

• Multi-Phototype Support

  Validated across all Fitzpatrick skin types

EU MDR 2017/745

Class IIb Medical Device

ISO 13485:2016

Quality Management System

IEC 62304:2006

Medical Device Software

Transform Your Dermatology Practice

Join leading healthcare institutions using Legit.Health Plus

Learn More

AI Labs Group SL

BAT Tower, Gran Vía 1, 48001 Bilbao, Spain

📧 support@legit.health | 🌐 www.legit.health

EMDN: Z12040192 | GMDN: 65975 | UDI: (01)8437025550005

Commercial Presentation Slide

This presentation slide is designed for commercial presentations to healthcare organizations.

Legit.Health Plus

Advanced AI Dermatology Diagnostics

1

Vision Transformer AI

State-of-the-art deep learning

2

239 ICD-11 Categories

Comprehensive diagnostic coverage

3

Clinical Severity Scoring

SCORAD, IHS4, AUAS integrated

4

FHIR API Integration

Seamless EHR connectivity

181,591

Training Images

9

Clinical Studies

99.7%

Accuracy

5 sec

Response Time

Transform Healthcare Delivery

Faster Diagnosis: Immediate AI-powered assessment

Objective Measurement: Quantifiable clinical signs

Improved Outcomes: Evidence-based treatment tracking

Cost Efficiency: Streamlined workflow optimization

MDR 2017/745: Full compliance achieved

Classification: Class IIb Medical Device

Notified Body: BSI (2797)

AI Labs Group SL

BAT Tower, Gran Vía 1, 48001 Bilbao, Spain

www.legit.health

support@legit.health

CE Marking Badge

The certification badge can be used across various promotional materials to highlight our MDR 2017/745 compliance.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001