Michael Barbella, Managing Editor12.07.23
Nortech Systems Incorporated's Suzhou, China, facility has been certified by the National Medical Products Administration (NMPA, formerly known as CFDA) to produce Class II medical devices for Asia customers.
“NMPA certification is a major step forward for Nortech Systems and our customers in the region,” Nortech Systems CEO Jay D. Miller said. “This certification is a testament to the hard work and dedication of our team in Suzhou and will enable us to better serve our customers in the Chinese and Asia markets. We are excited to be able to offer our customers in China and the rest of Asia the same high-quality products and services that we offer our customers in other parts of the world.”
The certification process was rigorous and included a comprehensive review of Nortech Systems’ quality management system, supply chain management, manufacturing processes, and product design, according to the company. The certification also ensures that Nortech Systems’ products meet the highest standards of safety and efficacy.
The certification from the NMPA allows Nortech Systems to produce Class II Medical Devices for customers in China and Asia. The company has produced Class II medical devices for the U.S. market in its U.S. Food and Drug Administration-registered facility located in Milaca, Minn. Class II medical devices are products used for medical purposes and are subject to more stringent regulations than other devices.
Nortech Systems Suzhou location features a state-of-the-art facility equipped with the latest technology and equipment. The facility is ISO 13485 certified and employs a team of highly trained and experienced engineers and technicians.
“We are committed to providing our customers with the highest quality products and services,” Nortech Systems Vice President of Operations for Asia Pacific, Feng Cao stated. “This certification from the NMPA is a testament to our commitment. There are presently very few companies in Suzhou that have been able to meet the rigorous requirements to achieve this certification.”
Nortech Systems provides design and manufacturing solutions for complex electromedical devices, electromechanical systems, assemblies, and components. Nortech Systems primarily serves the medical, aerospace and defense, and industrial markets. Its design services span concept development to commercial design, and include medical device, software, electrical, mechanical, and biomedical engineering. Its manufacturing and supply chain capabilities are vertically integrated around wire/cable/interconnect assemblies, printed circuit board assemblies, as well as system-level assembly, integration, and final test. Headquartered in Maple Grove, Minn., Nortech currently has seven manufacturing locations and design centers across the U.S., Latin America, and Asia. Nortech Systems is traded on the NASDAQ Stock Market under the symbol NSYS.
“NMPA certification is a major step forward for Nortech Systems and our customers in the region,” Nortech Systems CEO Jay D. Miller said. “This certification is a testament to the hard work and dedication of our team in Suzhou and will enable us to better serve our customers in the Chinese and Asia markets. We are excited to be able to offer our customers in China and the rest of Asia the same high-quality products and services that we offer our customers in other parts of the world.”
The certification process was rigorous and included a comprehensive review of Nortech Systems’ quality management system, supply chain management, manufacturing processes, and product design, according to the company. The certification also ensures that Nortech Systems’ products meet the highest standards of safety and efficacy.
The certification from the NMPA allows Nortech Systems to produce Class II Medical Devices for customers in China and Asia. The company has produced Class II medical devices for the U.S. market in its U.S. Food and Drug Administration-registered facility located in Milaca, Minn. Class II medical devices are products used for medical purposes and are subject to more stringent regulations than other devices.
Nortech Systems Suzhou location features a state-of-the-art facility equipped with the latest technology and equipment. The facility is ISO 13485 certified and employs a team of highly trained and experienced engineers and technicians.
“We are committed to providing our customers with the highest quality products and services,” Nortech Systems Vice President of Operations for Asia Pacific, Feng Cao stated. “This certification from the NMPA is a testament to our commitment. There are presently very few companies in Suzhou that have been able to meet the rigorous requirements to achieve this certification.”
Nortech Systems provides design and manufacturing solutions for complex electromedical devices, electromechanical systems, assemblies, and components. Nortech Systems primarily serves the medical, aerospace and defense, and industrial markets. Its design services span concept development to commercial design, and include medical device, software, electrical, mechanical, and biomedical engineering. Its manufacturing and supply chain capabilities are vertically integrated around wire/cable/interconnect assemblies, printed circuit board assemblies, as well as system-level assembly, integration, and final test. Headquartered in Maple Grove, Minn., Nortech currently has seven manufacturing locations and design centers across the U.S., Latin America, and Asia. Nortech Systems is traded on the NASDAQ Stock Market under the symbol NSYS.