Competence | Precision-Engineered TENS/EMS Muscle Stimulators by ZMI

Competence | ZMI has provided comprehensive services from product development to the manufacturing, providing complete product validation, and other professional services for medical device certification in various countries.

Competence

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

Product Certification

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

Post Market Surveillence

• PMCF
• PMS
• GUDID

Competence | Sterile and Non-Sterile Incontinence Probes for Modern Healthcare Solutions by ZMI

Based in Taiwan since 1990, ZMI Electronics, Ltd. is a leader in the medical device sector, specializes in high-quality OEM/ODM services, catering to top global medical brands. Our extensive portfolio includes Medical Electrodes, Rubber Electrodes, Self-adhesive Electrodes, Hydrogel Pads, Sponge Electrodes, Vacuum Cup Electrodes, Medical Leadwires, and cutting-edge TENS/EMS muscle stimulators. We also offer Sterile and Non-sterile Incontinence Probes, Spinal Cord Traction devices, and technology for Ultrasound and Shortwave Diathermy.

Early ZMI mainly produced automotive constant speed controller. After several years, the company transformed into a medical equipment and components supplier, focusing on providing OEM and ODM services for internationally renowned medical equipment brands. The products include electrotherapy, phototherapy, sonotherapy, hyperthermia, force therapy and other equipment and accessories commonly used in physical therapy. The clinical applications cover neurology, rehabilitation, orthopedics, homecare and personalized medicine.

ZMI has been offering our customers high quality medical device manufacturing since 1990, both with advanced technology and 25 years experience, ZMI ensures each customer's demands are met.