Chronic wound care therapy Device

This FDA-approved Class II medical device (K233077) was developed under my leadership alongside a multinational team of engineers and medical advisors.

The device introduces a novel approach to chronic wound treatment, utilizing non-coherent light therapy and advanced camera systems to enhance operator precision and ensure patient safety.

Due to strict IP protection, limited details can be shared, but the system integrates custom and OTS PCBs, supports diverse communication protocols and programming languages, and features an intuitive user interface. I led the project from concept through to production.

• Compliant with IEC 60601-1, 60601-1-2, 62471, 62304, 60601-2-57, FDA software guidelines for medical devices, and ISO 13485.

• Firmware designed with a hard real-time premise.

• Controls a total of 360W of LEDs distributed over 3 different wavelengths.

• Carefully designed patient cooling system.

• Integration of multiple cameras, PCBs, control devices, and complex sensors.

• Managed the development of the device, ensuring all requirements were met.

• Developed hardware, embedded firmware, and test/validation procedures using C, Python, and MATLAB.

• Guided the team in implementing critical features and ensuring project alignment.

• Created regulatory documentation for compliance in the USA, Europe, and Brazil.

• Supervised production procedure development and validation tasks.