Competence

Provides OEM/ODM medical device development, manufacturing, validation, and international certification.

Competence

Competence

Our competitive edge stems from exceptional R&D, lean production, reliable suppliers, and stringent regulatory compliance, ensuring market competitiveness and high-quality products.


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

Product Certification

• EMC / RF Testing
• Safety Testing
• ISO / IEC Standands Testing
• Biocompatibility Testing

Post Market Surveillence

• PMCF
• PMS
• GUDID

Top Medical Device Manufacturer in Taiwan - Custom Solutions

ZMI provides OEM and ODM medical devices, offering high-quality electrotherapy, phototherapy, sonotherapy, hyperthermia, and force therapy equipment. Our solutions also include Medical Electrodes, Medical Leadwires, wireless TENS and EMS units, widely used in physical therapy, rehabilitation, neurology, orthopedics, and homecare.