Nortech Systems Suzhou Facility Certified to Produce Class II Medical Devices for Asia Market
October 04 2023 - 4:30PM
Business Wire
Nortech Systems Incorporated (Nasdaq: NSYS) (the "Company"), a
leading provider of engineering and manufacturing solutions for
complex electromedical and electromechanical products, is proud to
announce that its Suzhou, China facility has been certified by the
National Medical Products Administration (NMPA, formerly known as
CFDA) to produce Class II Medical Devices for customers in Asia.
This certification marks a major milestone for Nortech Systems and
its customers in the region.
“NMPA certification is a major step forward for Nortech Systems
and our customers in the region,” said Nortech Systems CEO, Jay D.
Miller. “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,” said Miller.
The certification process was rigorous and included a
comprehensive review of Nortech Systems’ quality management system,
supply chain management, manufacturing processes, and product
design. 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 been a leading producer of Class II Medical Devices
for the United States market in its FDA-registered facility located
in Milaca, Minnesota. Class II Medical Devices are products that
are intended to be used for medical purposes and are subject to
more stringent regulations than other products.
Nortech Systems Suzhou facility is a state-of-the-art facility
that is equipped with the latest technology and equipment. The
facility is ISO 13485 certified and has a team of highly trained
and experienced engineers and technicians.
“We are committed to providing our customers with the highest
quality products and services,” said Nortech Systems Vice President
of Operations for Asia Pacific, Feng Cao. “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 is a leading provider of design, engineering,
and manufacturing services for the medical, industrial, and
aerospace markets. The company has a global presence with
facilities in the United States, Mexico, and China.
About Nortech Systems Incorporated
Nortech Systems is a leading provider of design and
manufacturing solutions for complex electromedical devices,
electromechanical systems, assemblies, and components. Nortech
Systems primarily serves the medical, aerospace & 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.
Nortech's website is www.nortechsys.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20231004046684/en/
Alan Nordstrom, Acting CFO anordstrom@nortechsys.com
952-444-3733
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