Competence
We base our competitive edge on outstanding R&D, lean production, critical supplier capabilities, and regulatory compliance to ensure market competitiveness and deliver excellent products and services.
R&D Capabilities
• Electronics & Mechanical Design (PCB, 2D / 3D artwork design)
• Wifi / Bluetooth / Inertial Sensor & Antenna Design
• Wearable & IoT Software/Hardware Design
• Rapid Prototyping (PCB / 3D Printing / CNC Mockup)
• Safety & EMC Troubleshooting (ISO/IEC Standard)
• Performance Testing & Quality Planning
• Reliability Planning & Testing
• Process & Software Validations
• Technical Files Documentation
• Key Components Evaluation and Replacement
Lean Manufacturing
• Modern & Automated Production Line
• LEAN Production Management (ANSI/ESD S4.1 and STM4.2 Anti-ESD compliance)
• Tablet entry eBR (Batch Records for Production & QC)
• TQM (methological analysis, CAPA, FMEA, 5-why analyais)
Vendor Capabilities
• PCB (2 / 4 / 8 mutiplle layer) BGA / SMT / DIP fabrication (SPI & AOI quality control)
• Injection Moulding (single / dual complex injection, medical grade PC / TPE / TPU / LSR moulding)
• Metal Process (Die cutting / Laser cutting)
• UX / UI Design
• 3rd Party Medical Safety & EMC / EMI Testing Lab (ISO 17025)
Regulatory Compliance
Quality System• ISO 13485
• 21CFR820
• MDSAP
• GMP/QSD
• EMC / RF Testing
• Safety Testing
• ISO / IEC Standands Testing
• Biocompatibility Testing
• PMCF
• PMS
• GUDID