TT’s Cleveland, Ohio site gains FDA registration status for medical device manufacturing

Woking, UK, 30 March 2021 - TT Electronics, a global provider of engineered electronics for performance critical applications, today announced that the U.S. Federal Drug Administration (FDA) has confirmed registration for its Cleveland, Ohio manufacturing facility. The registration allows the company to manufacture finished medical instruments and devices, like imaging and diagnostic systems, in the USA.

As an FDA registered establishment, the facility is now recognised under the stringent standards of the FDA, reinforcing the company’s commitment to providing the most comprehensive range of services to its global customers.

The registration follows TT’s earlier announcement of its new, advanced manufacturing facility in Asia which allows the company to further broaden its capabilities in direct response to demand from life science customers.

“This is an important step in our healthcare industry growth strategy. Our FDA designation will provide a significant advantage in supporting our current customers, many of whom are global leaders in their fields,” said TT Electronics EVP, Michael Leahan. “TT has been supporting medical and life science technology innovators for over a decade. Our customers can now leverage our expanded capabilities in the USA to manufacture and deliver finished, complex medical products – with the same world class service experience that they’ve come to expect from TT.”

Manufacturing facilities that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This registration provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

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