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TT Electronics Receives FDA Registration for Asia Manufacturing FacilityDecember 8, 2023 | TT Electronics
Estimated reading time: 1 minute
TT Electronics, a leading provider of global manufacturing solutions and engineered technologies, announced today that one of its Asia electronics manufacturing facilities has received approval from the Food and Drug Administration (FDA), through its premarket approval (PMA) supplement evaluation process, to manufacture Class IIa devices on behalf of global medical OEM customers.
The FDA registration of TT Electronics’ manufacturing site in Dongguan, China underscores the company's commitment to upholding the highest standards of quality, safety, and regulatory compliance in the provision of manufacturing solutions for global healthcare markets.
"We are thrilled to announce the FDA registration of our Dongguan China manufacturing site," commented Michael Leahan, Chief Operating Officer at TT Electronics. "TT Electronics has been supporting medical and life science innovators for over a decade. This achievement is a testament to our relentless pursuit in delivering manufacturing excellence for our customers and contributing to the development of safe and reliable medical products.
“Having multiple FDA registered facilities enables TT to continue supporting our customers’ growth in international markets and reinforce our reputation as a trusted provider of electronic manufacturing solutions for products that help shape the future of healthcare.”
TT Electronics continues to broaden its global manufacturing offering with a number of footprint expansions announced earlier this year. A new facility in Mexico will be operational in 2024 and will also work towards being ISO 13485 registered.
KYZEN, the global leader in innovative environmentally friendly cleaning chemistries, is thrilled to announce the premier of a new online video series “Ask Dr. Adam.”
I-Connect007 has just released the latest episode of its podcast series, On the Line with..., which focuses on designing for reality in the electronics industry. In this episode, host Nolan Johnson talks with ASC Sunstone VP/Manager Matt Stevenson about CAD tool features and data formats that help designers make better decisions and transfer better designs to manufacturing.
TT Electronics, a leading provider of global manufacturing solutions and engineered technologies, proudly announces the grand opening of its newest manufacturing facility located in Mexicali, Mexico.
The Semiconductor Industry Association (SIA) released the following statement from SIA President and CEO John Neuffer in response to the semiconductor manufacturing incentives announced by the U.S. Department of Commerce and GlobalFoundries.
One of my great joys as a grandfather of eight is spending time with them at the park. It doesn't take too long until I'm getting stuck on a slide that is too small for me or on the seesaw, with me on one side and them trying to lift me. At that point, they learn some harsh lessons in physics and how heavy Grandpa really is. A seesaw is a relatively simple device, but it’s a great way to explain a rather complex concept in PCB design: design tradeoffs. Each decision made throughout a design comes with inherent pros and cons.