Manufacturing & Quality
LEIJEX runs an ISO 13485-based quality system covering R&D, incoming inspection, final assembly and burn-in, with CE and FDA pathways per target market.
End-to-End
Quality Loop from R&D to Delivery
R&D Validation
Energy output, temperature control and safety parameters are validated at platform level.
Incoming Control
Qualified supplier system for core optical and electrical components with batch traceability.
Final QC
Every unit passes energy calibration, electrical safety and burn-in tests before shipment.
Registrations
ISO 13485-based CE / FDA pathways pursued per market, with bilingual documentation.
Compliance
Professionalism, Built on Safety
Quality System
ISO 13485 quality management across design and manufacturing.
Certification Path
CE and FDA pathways planned per market; refer to formal certificates.
Evidence-Based
Evidence-based product claims; no treatment-effect promises.
Product Information Notice
Content on this website is for product information and communication only. It does not constitute medical advice, diagnosis or treatment promises. Official technical documentation and local regulations prevail.