Welcome FDA visit our company

September 23, 2022

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On July 21st, the Department of Health and Human Services United States Food and Drug Administration Winchester Engineering and Analytical Center (FDA in short) sent Electronics Engineer & Laser Expert Mr. Emir Galevi, and Magnetic Resonance and Electronic Products Branch Chief Mr. Patrick Hintz to our company for a visit. Our General Manager King Chen, Vice-General Manager Ken Chen, Technical Manager Tom, and VIP Manager Amy participated in the meeting with Mr. Emir and Mr. Patrick.

Amy made a detailed report and presentation of our business development in the USA. Since 2012, our company has kept more than 60% growth in the US market. With such rapid growth, our company will pay more attention to improving the machinery safety and functions to meet US government requirements. Later, Amy also presented Mr. Patrick Hintz (the Magnetic Resonance and Electronic Products Branch Chief) with all of our FDA reports and USA shipping records and applying rules in the past years.

Accompanied by our General Manager King Chen, the two FDA experts visited our Production line including the mechanical assembly production line and electrical assembly line, Laserquality testing line. They checked Testing instruments, Calibration records, Labels, etc. Our technical manager Tom accompanied us to give some interpretation of the detailed production process and made a deep discussion with Mr.EmirGalevi about mechanical details and laser safety.

Tom also introduced our new product- the NOVA serieslaser system to them. The NOVA series is designed with dual safety channel control, an independent safety logic center, and energy-saving control, all of this help to upgrade the machine safety to a higher level to meet European and US market requirements.

At last, both Mr. Emir and MrPartrick confirmed that our Nova laser systems have reached the Class 1 laser product standard under the FDA ruler.

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