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
02Product Certification
  • EMC/RF Testing
  • Safety Testing
  • ISO/IEC Standands Testing
  • Biocompatibility Testing
03Post 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)

ABOUT

  • About ZMI
  • Vision & Mission
  • Philosophy
  • History
  • Certification
  • Registration
  • Factory Overview

SOLUTION

  • Overview
  • Physical Therapy
  • Biomedical Technology

VALUE SERVICE

  • CRM
  • DHR
  • Supply Chain
  • UDI
  • Regulatory Consultancy
  • Project Management

COMPETENCE

  • R&D Capabilities
  • Regulatory Compliance
  • Lean Manufacturing
  • Vendor Capabilities

PRODUCT

  • Medical Leadwires
  • Medical Electrodes
  • Specialized Accessories
  • OEM/ODM Products

CONTACT US

  • Contact Form
  • Contact Information
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