Reading time ( words)
SMTC Corporation (SMTC), a global EMS provider, today announced the licensing by the State of California Food and Drug Branch (FDB) to manufacture Class 1 and Class 2 medical devices. 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.
Prior to issuing the license, the FDB inspected the San Jose manufacturing facility. SMTC 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. In addition to achieving this new FDB licensing SMTC facility in San Jose is also FDA Establishment Registered. SMTC's manufacturing facilities in San Jose, Mexico and Canada have already achieved the ISO 13485:2003 registration requirements (Quality System Certification for Medical Devices). These Quality capabilities strengthen SMTC's position within the Medical Device Industry, and showcase their expertise in offering complex turn-key and engineering solutions to OEM customers in general.
Paul Blom Executive Vice President of Operations for SMTC, commented, "The quality standards achieved through this new licensing, coupled with our existing quality management system, provides SMTC customers with an excellent medical device service offering, and further strengthens our ability to add value in this rapidly growing market."
About SMTC CorporationSMTC Corporation, founded in 1985, is a global provider of flexible and customized EMS including PCBA production, systems integration and testing, enclosure fabrication, as well as design, engineering and supply chain management services. SMTC facilities span a broad footprint in Mexico, United States, Canada and China, with more than 1,800 full-time employees. SMTC services extend over the entire electronic product life cycle, from the development and introduction of new products through to the growth, maturity and end-of-life phases. SMTC offers fully integrated contract manufacturing services with a distinctive approach to global OEMs and emerging technology companies primarily within industrial, medical, computing and communication market segments. SMTC is a public company incorporated in Delaware with its shares traded on the Nasdaq National Market System under the symbol SMTX and on the Toronto Stock Exchange under the symbol SMX. For further information, visit www.smtc.com.