ZMI Electronics, Ltd.
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COMPETENCE
COMPETENCE
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
Regulatory Compliance
Quality System
ISO13485
21CFR820
MDSAP
GMP
02
Product Certification
EMC/RF Testing
Safety Testing
ISO/IEC Standands Testing
Biocompatibility Testing
03
Post Market Surveillence
PMCF
PMS
GUDID
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)
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