East West Manufacturing’s Medical Division manufactures and assembles Class II Medical Devices to exact customer specification in compliance with ISO 13485 and FDA requirements, in our wholly-owned facilities outside of Ho Chi Minh City, Vietnam.
Medical Device Manufacturing complements our Electronics Manufacturing Services (EMS) as Medical Devices have increasingly gravitated from connect to M (Mobile) Health. Many Medical Devices have electronic components containing sensor and algorithms to transport and interpret data for physicians. These innovative devices connect via Mobile, Wireless, Bluetooth, RFID, and various remote sensing communication tools.
Our Medical Device Manufacturing and Electronics Manufacturing are supported by injection molding, stamping, and assembly operations in Vietnam under complete Western Management.
“Our valuable partnership with East West goes back many years. Their ability to add value along our supply chain has helped us grow at a rapid pace. East West’s unique ISO 13485 certified facilities in Vietnam allow us to expand into new markets and continue to grow our business.”
Paul Taggert | Age Sciences
Current Medical Devices include hand-held microderm abrasion device, a revolutionary new crutch system, devices that sense post-traumatic abnormalities in brain wave function, an electro-mechanical medical device that reduces the spread of infection in clinical settings, and catheter devices used in specific applications.
We have years of experience with 3rd party agency approvals such as FDA, UL, RoHS, and CE. Our team sources FDA grade plastic materials. Our Class II Medical Device Manufacturing is supported by a Manufacturing Information System on the production floor which captures real-time data. Our Quality Team ensures our facility and processes meet ISO 13485 standards with our concentration on plastic and metal parts and electro-mechanical Medical Device Assemblies.
Medical Device Manufacturing supported by Assembly that includes 4 color retail packaging.
We support global medical organizations and earlier stage companies manufacturing offshore to achieve economies of scale or diversification of their supply chain.