Florida Company Receives ISO 13485 Certification
HAVANA, Fla.—TeligentEMS (www.teligentems.com) recently announced that it has achieved ISO 13485 certification, an internationally-recognized quality standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet the specific customer and regulatory requirements applicable to medical equipment.
"TeligentEMS is committed to servicing the medical equipment market and, consequently, set ISO 13485 certification as a strategic company initiative," said company president Chris Eldred in a statement. "Third party accreditation of our quality system provides positive acknowledgement to the efforts, actions, and results of the employees of TeligentEMS."
TeligentEMS is an ISO 9001:2008, ISO 13485:2003 small-business certified, ITAR registered, electronics manufacturing services (EMS) provider. The company produces electronic, mechanical, and system-level assemblies, emphasizing extensive radio frequency, as well as digital and analog technologies for OEM customers in the medical, instrumentation, military, communications, and industrial markets. Services provided include prototyping, new product introduction (NPI), global procurement, supply chain management, product assembly, product test, functional test development, depot repair, and order fulfillment.
Mike Wallace, vice president of business development, noted in a statement, "Our customers and prospective customers in the medical sector increasingly expect ISO 13485 from their supply chain partners. Ideally, certification will further accelerate growth in our fastest growing market sector."
Eldred added, "Achieving ISO 13485 certification is an excellent example of our company's commitment to continuous improvement. Certification was achieved through incremental enhancements and refinements to our existing robust ISO 9001 certified quality system."
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