Processing & assembly of medical devices to Japanese standards - ISO13485

Our company has been officially registered with the Japanese Ministry of Health, Labour and Welfare (MHLW) as an overseas medical device manufacturer, and has also achieved ISO13485 (BSI) certification. At our factory located in Hai Phong province, Vietnam, we possess integrated production capabilities ranging from sheet metal processing, welding, surface treatment, and assembly to quality inspection.
We strictly adhere to traceability and quality control requirements in the medical industry, thereby performing component processing and medical device casing assembly with high reliability.
Key Features:
- Registered as an overseas medical device manufacturer meeting Japanese standards
- Quality management system compliant with medical device standards, with ISO13485 (BSI) certification
- Dedicated production line for medical devices: from metal processing – welding – assembly
- Burr-free processing with automatic deburring equipment immediately after sheet cutting
- Resident Japanese experts directly conduct quality inspection and assessment according to medical device standards
Equipment and Production Capabilities:
- Materials: Stainless steel (SUS304, SUS430), aluminum, copper, steel
- Sheet metal processing: Fiber laser, punch & laser combination machine, press brake, automatic deburring machine
- Welding: TIG welding, spot welding, robotic welding
- Assembly: From sub-assembly, wiring to electrical inspection and operational testing
- Quality management: 3D measurement, coating thickness inspection, visual inspection, and component traceability management
Typical Product Applications in the Medical Industry:
- Casings and components for medical analysis equipment
- Metal casings and components for suction, washing, and diagnostic equipment
- Devices such as control panels, power supply units for medical facilities
LEO ELECTRONICS Vietnam is a company specializing in precision metal processing and complete assembly, with global supply capabilities in the medical device sector, holding ISO13485 certification and meeting Japanese standards.
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