Chronic wound care therapy device

Advanced wound therapy system based on violet and IR light with smart monitoring

Wound Assessment Device - Detailed prototype view

System Characteristics

Sensors and Measurement

Thermal Cam - 640x480 px - ±1°C
Bioluminescence camera: 3840x2160 px
Measurement camera: 3840x2160 px
Presicion distance sensor: ±1mm
Air compressor and pressure sensor for accurate patient cooling
±10% irradiance variance over the treatment area

Hardware Capabilities

Total of 360W of non-coherent light power
8 different wavelengths for treatment and diagnostics
Biocompatible patient cooling system
4 different cameras communicating over a custom USB 3.2 hub

Interface and Safety

System validated by Usability tests
Device fully tested and compliant with multiple standards.
User centered design
Initial GDPR compliance implementation plan
End-to-end data encryption

Certifications and Regulatory Compliance

IEC 60601-1

Basic Safety and Essential Performance

ISO 13485

Medical Devices - Quality management systems

FDA Approved - 510k

K233077

IEC 62304

Medical device software - Software life cycle processes

IEC 62471

Photobiological safety of lamps and lamp systems - Risk Group 2

Project Description

This revolutionary Class II medical device, FDA-approved under K233077, was developed by a multinational team of 10 engineers and medical advisors under my leadership.

The device employs a groundbreaking approach to chronic wound treatment, combining non-coherent light therapy with advanced camera systems to assist operators and ensure patient safety.

This complex system integrates multiple custom and OTS PCBs, supports a variety of communication protocols and programming languages, and features an intuitive user interface designed for seamless operation. Led it from the start to the production.