Adherence to FDA quality standards will boost ability of fabrication facility to produce pilot-scale devices for NextFlex members and customers
Image: NextFlex complies with FDA standards for medical devices. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.org
NextFlex, America’s Flexible Hybrid Electronics (FHE) Manufacturing Institute, today announced that its Technology Hub’s fabrication facility in San Jose now complies with FDA manufacturing standards for medical devices.
NextFlex’s Quality System adheres to the intent of the Food and Drug Administration’s (FDA) regulations for good manufacturing practices. All medical device products and components produced at the NextFlex facility will be manufactured consistently to meet Quality System Regulations (QSR) requirements.
“The NextFlex Technology Hub has come a long way in a short time and is now FDA-compliant for the manufacture of medical devices. We follow current good manufacturing practices in order to meet the strict requirements of the FDA,” said Art Wall, director of Fab Operations at NextFlex. “NextFlex is now in a position to support the goals of medical device manufacturers by implementing the QS regulation known as 21 CFR Part 820. This quality framework assures customers that the devices that NextFlex produces are fully compliant with current applicable regulations.”
As part of its mission to advanced FHE manufacturing in the U.S., NextFlex’s facility has two cleanrooms for printing, device integration and lab space for testing and measurement, with a greater collection of FHE print capability under one roof than anywhere else in the world. With all medical devices produced at this facility now FDA-compliant, both large companies and startups alike can fill the gap between prototyping and full-scale manufacturing in a low-risk, cost-efficient way by using NextFlex’s full complement of FHE design, development and manufacturing services.
Source: Company Press Release