Molex Incorporated, a global manufacturer of electronic solutions, announced that the Molex Dongguan, China facility is now registered with the U.S. Food and Drug Administration (FDA) as a compliant manufacturer of Class I medical devices.
Manufacturers involved in the production and distribution of medical devices intended for use in the U.S. must register annually with the FDA regulatory agency, which is under the auspices of the U.S. Department of Health and Human Services.
"As a trusted partner providing integrated solutions for disposable patient sensors and other medical products, we are pleased to give Molex customers the added assurance of U.S. FDA registration," states Justin Spitzer, business development manager, Molex. "Molex Dongguan adheres to stringent quality systems that ensure our products meet or exceed FDA Class I standards and requirements for medical devices used in the care of patients."
Part of an ongoing process improvement plan by the Molex printed circuit products group, U.S. FDA registration confirms the Dongguan China site’s adherence with FDA inspections, tracking and traceability criteria. Molex Dongguan and other Molex manufacturing facilities maintain certification in ISO 9001 quality management and ISO 14001 environmental management.
"Molex enables medical device designs that drive healthcare innovation. Patient monitors are evolving from bedside equipment to smaller, lightweight, integrated solutions. As high volume markets expand for portable and wearable patient monitors requiring quality disposable sensors, we are pleased to provide medical device manufacturers the quality FDA registered products they need at a competitive price point," adds Spitzer.
In addition to disposable sensor technologies, the Molex printed circuit products group provides flexible print circuits, printed circuit boards, assemblies, membrane switches, user interfaces and capacitive touch technologies.