Medical Device Manufacturing
East West Manufacturing offers Medical Device Manufacturing in our own three-building complex in Vietnam; our Boston, Charlotte, and Wisconsin locations; as well as our nearshore facility in Costa Rica. These East West’s factories are certified to ISO 9001:2015, ISO 13485:2016, and ISO 14001 Quality Management Systems standards and guidelines.
The addition to ISO Certifications, our facilities complement our Medical Device manufacturing services with Electronic Manufacturing Services (EMS), injection molding, stamping, and assembly operations. With ISO 13485:2016 certification, our factories are qualified to manufacture plastic and metal parts and electro-mechanical assemblies for the medical device industry.
Our Medical Device Manufacturing Capabilities Include:
- Plastics - Injection Molding, Insert Molding, Over-Molding, Pad Printing, Ultra Sonic Welding, and Assembly
- Metals - Stamping, Machining, Fabrication
- Electrical/Electronic - PCBAs, Electrical Assembly, Electronic Assembly, Engineered Components, SMT, In-line Testing
Current medical devices we manufacture 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.