Rezalox Therapy System
Medical Laser Devices
Company: GlobaLASEReach
Sector: Medical Devices / Pain Management
Scope: Mechanical design, cooling system design, IP documentation, Project Management, ISO 13485 QMS development, ISO 14971 risk analysis
Status: Prototype completed. Ongoing development and testing.
Summary:
The Rezalox™ Therapy System is a high-powered (60W), dual-wavelength (810nm and 980nm) photobiomodulation (PBM) laser device designed to treat acute and chronic pain syndromes, including pelvic and bladder pain. ZEDion led the mechanical engineering efforts, developing a patented CO₂-based cooling system for the laser treatment head, and coordinated with electrical and software teams to ensure seamless integration. Additionally, ZEDion spearheaded the creation of intellectual property documentation and established a compliant ISO 13485 Quality Management System (QMS), including conducting ISO 14971 risk analyses.
ZEDion’s Development Role:
Mechanical Design:
Developed the complete mechanical architecture of the Rezalox™ system, focusing on ergonomic design and durability.
Engineered a patented CO₂-based cooling mechanism for the laser treatment head, enhancing patient safety and device performance.
Regulatory & Quality Systems:
Led the development and implementation of an ISO 13485-compliant QMS, ensuring adherence to medical device manufacturing standards.
Conducted comprehensive ISO 14971 risk assessments, identifying and mitigating potential hazards associated with device operation.
Intellectual Property:
Authored detailed IP documentation, including system diagrams and descriptions, to support patent applications and protect proprietary technologies.
Technologies Utilized:
CAD software (Autodesk Inventor) for mechanical design
Greenlight Guru for QMS implementation
Compliance & Standards:
ISO 13485: Medical Devices – Quality Management Systems
ISO 14971: Application of Risk Management to Medical Devices
RoHS compliance for material selection
