Promotional Materials
Purpose
This section showcases promotional materials for the device, 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:
- Regulatory Compliance: Meeting MDR 2017/745 requirements for promotional material documentation prior to certification
- Market Communication: Showcasing our achievement of CE marking and the advanced capabilities of our AI-powered dermatology diagnostic device
Validated Clinical Benefits
All promotional claims are based on validated clinical benefits supported by clinical validation studies:
- Diagnostic Accuracy: The device improves accuracy of healthcare providers during diagnosis of dermatological conditions
- Objective Severity Assessment: The device measures the degree of involvement of disease objectively, quantitatively, and reproducibly by quantifying clinical signs (such as erythema, desquamation, and other visual markers)
- Resource Optimisation: The device reduces waiting times for skin-related medical consultations by providing additional relevant clinical information
- Referral Precision: The device improves the precision of healthcare providers during referral, increasing the adequacy of referrals
- Remote Care Support: The device improves accuracy during remote diagnosis of skin conditions and precision during remote referral
The device quantifies the intensity of clinical signs (such as erythema, desquamation, papules, etc.), which are the components that comprise severity scoring systems. While this measurement supports clinical workflows that use scoring systems, the validated claims relate to the objective quantification of clinical signs, not the calculation of specific scoring system values.
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
ICD-11 Categories
Comprehensive diagnostic coverage
Reproducibility
Objective and consistent measurements
Processing Time
Instant results via API
HL7 Compatible
Seamless EHR integration
Clinical Excellence
Objective Severity Measurement
Quantifies clinical signs objectively and reproducibly
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
Vision Transformer AI
State-of-the-art deep learning
239 ICD-11 Categories
Comprehensive diagnostic coverage
Objective Clinical Sign Quantification
Measures intensity of erythema, desquamation, and more
FHIR API Integration
Seamless EHR connectivity
181,591
Training Images
9
Clinical Studies
ICC ≥0.7
Reproducibility
5 sec
Response Time
Transform Healthcare Delivery
Enhanced Diagnostic Accuracy: Improves HCP diagnosis of dermatological conditions
Objective Severity Assessment: Quantifies clinical signs reproducibly and consistently
Reduced Waiting Times: Provides additional clinical information for faster decisions
Improved Referral Precision: Increases adequacy of dermatology referrals
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