Medical Device Processing & Assembly to Japanese Standards – ISO13485 Certified

Our company is officially registered with Japan’s Ministry of Health, Labour and Welfare (MHLW) as a foreign medical device manufacturer and has obtained ISO13485 (BSI) certification.At our factory in Hai Phong, Viet Nam, we offer a fully integrated production system- from sheet metal processing, welding and surface treatment to assembly and quality inspection
We strictly comply with traceability and quality control requirements in the medical industry, enabling us to reliably process components and assemble medical device frames and housings
Key Features:
- Officially registered as a foreign medical device manufacturer meeting Japanese standards
- Certified with ISO13485 (BSI), compliant with medical device quality management systems
- Dedicated production line exclusively for medical devices: from sheet metal processing – welding – assembly
- Burr-free processing achieved through automated deburring equipment immediately after sheet cutting
- Resident Japanese experts perform on-site inspections and evaluations according to medical equipment standards
Equipment & Production Capabilities:
- Materials: Stainless steel (SUS304, SUS430), aluminum, copper, steel
- Sheet Metal Processing: Fiber laser, combined punch & laser machine, press brake, automatic deburring machine
- Welding: TIG welding, spot welding, robotic welding
- Assembly: From component assembly and wiring to electrical testing and operational checks
- Quality Control: 3D measurement, coating thickness inspection, visual inspection, and traceability management of parts
Representative Medical Applications:
- Frames and components for medical analysis equipment
- Metal housings and parts for suction, washing, and diagnostic devices
- Devices such as control panels and power supply units for healthcare facilities
LEO ELECTRONICS Vietnam specializes in precision metal processing and complete assembly. We offer global supply capabilities for the medical device industry, certified to ISO13485 and compliant with Japanese standards.
Please download our PDF brochure or contact us for more details.