|
Medical
Medical original equipment manufacturing (OEM) companies have unique customer requirements. Medical products are often used to detect, monitor and/or stop diseases in the human body. The accuracy and reliability of medical equipment is paramount and patient safety is critical. SMTC partners with leading medical device OEM companies to provide advanced electronic manufacturing services in the medical and life sciences market sector. Our customers are served by manufacturing and technology centers strategically located in the United States, Canada, Mexico and China. Medical OEMs leverage the full range of value added services including product design, prototyping, procurement, test development, assembly, final system build, comprehensive supply chain management, global distribution and after sales support.
| Our Product Expertise |
- Diagnostic devices
- Imaging and laboratory equipment
- Patient monitoring systems
- Infusion pumps and dispensing systems
Our capabilities, capacity and structure help reduce the time to market and deliver competitive advantage. We work together with our medical customers to deliver operations excellence and patient safety. | | |
 |
Medical Product Experience |
|
|
Medizone International's AsepticSure™ Medical Disinfection System - "In meeting with potential manufacturing partners it was soon clear that SMTC would be a great fit for us. They are able to provide a full range of complex electronic manufacturing and integrated service solutions at their Canadian facility, including New Product Introduction (NPI) services and PCBA manufacturing and system level integration... |
|
Read more |
|
|
|
All SMTC facilities adhere to the "Copy Exact" methodology. Every SMTC facility employs the same manufacturing equipment and software systems and follows the same standardized processes. "Copy Exact" allow for a seamless and timely transition of production between facilities helping medical customers reach their cost and volume targets faster. Medical markets are tightly regulated. SMTC is registered to the ISO 9001:2008 quality management system standard and ISO 13485:2003 certified. ISO 13485 is an internationally recognized quality management system and standard for the manufacturing of medical devices. It governs the safe deployment and execution of medical products including the ability to deliver product recall, traceability, record retention, and risk management.
SMTC completed the required compliances and received licensing by the State of California Food and Drug Branch (FDB) to manufacture Class 1 and Class 2 medical devices at their San Jose, California facility. The FDB, which partners with the Food and Drug Administration (FDA), has authorized SMTC to operate under the rigorous quality guidelines of California's Device Manufacturing Licensing laws. SMTC have demonstrated compliance with all applicable state laws including the federal Good Manufacturing Practice (GMP), and the Quality System Regulations (QSR). Manufacturers must renew their license annually, and the FDB conducts periodic renewal inspections.
Clean Room Capabilities
SMTC’s medical device manufacturing services include production, assembly and packaging capabilities in a Class 10,000 environment in our SMTC San Jose & SMTC Mexico facilities. Our process control systems make it possible for SMTC to handle Low-Mid volume programs. By employing value-added work cells that include controlled material handling, process monitoring systems, and custom area for assembly and packaging, SMTC is able to ensure compliance to quality requirements, tight control to specifications, and part repeatability for Low-Mid-volume production.
Continuous innovation and operational excellence is why we are the manufacturing partners to innovators around the world.
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|