- Proven design and manufacturing capabilities for interventional cardiovascular devices in Vietnam
- Capabilities in key technologies for medical device manufacturing, including laser processing
- ISO 13485:2016-certified quality management system for specially-controlled medical devices
The Nissha Group offers medical device CDMO services through its manufacturing platform, which has a proven track record in the mass production of interventional cardiovascular devices.
USM Healthcare, our Vietnam-based manufacturing site, designs and manufactures specially-controlled medical devices, including drug-eluting stent delivery systems. Combined with Nissha’s quality management and engineering capabilities, USM Healthcare provides a seamless end-to-end CDMO solution from development to mass production.
Nissha offers medical device CDMO services tailored to customer specifications,
supported by its manufacturing track record and quality management system
Manufacturing Track Record for
Interventional Cardiovascular Devices
USM Healthcare has extensive experience in designing and manufacturing drug-eluting stent delivery systems for interventional cardiovascular applications.
This expertise is applied in its CDMO services, supporting process design, mass production ramp-up, and the stabilization of product quality in contract manufacturing.
High-precision Laser Processing Technologies
Interventional cardiovascular devices, including stents, require extremely fine and complex structures, making high-precision laser processing essential.
USM Healthcare, part of the Nissha Group, has expertise in manufacturing technologies such as high-precision laser processing of metal tubes and can support design, processing, and process development tailored to customer specifications.
Quality Management System
USM Healthcare’s manufacturing facility has established a stringent quality management system and holds certifications for ISO 13485:2016, ISO 14001:2015, and ISO 9001:2015.
The facility is equipped with approximately 1,100 m² of cleanroom space meeting ISO Class 7 (Class 10,000) and ISO Class 8 (Class 100,000) standards, enabling assembly, processing, and packaging of specially-controlled medical devices, including those for interventional cardiovascular applications.
Manufacturing Site
USM Healthcare, the Nissha Group’s manufacturing site in Vietnam, operates a facility of approximately 10,000 m² in Saigon Hi-tech Park, Ho Chi Minh City. As a medical device CDMO, it leverages its established equipment and technological infrastructure to support the timely supply of products to major Asian markets, including ASEAN, and the development of a flexible supply chain.
Location: Saigon Hi-tech Park, Long Thanh My Ward, HCMC
Website：https://usm.com.vn/
