NextFlex’s Technology Hub Complies with FDA Standards for Manufacturing of Medical Devices


Reading time ( words)

NextFlex, America’s Flexible Hybrid Electronics (FHE) Manufacturing Institute, has 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.

About NextFlex

NextFlex, America’s Flexible Hybrid Electronics Manufacturing Institute, is a leading force in the Manufacturing USA network of institutes. Formed through a cooperative agreement between the U.S. Department of Defense (DoD) and FlexTech Alliance, NextFlex is a consortium of companies, academic institutions, non-profits and state, local and federal governments with a shared goal of advancing U.S. manufacturing of FHE. Since its formation in 2015, NextFlex’s elite team of thought leaders, educators, problem solvers and manufacturers have come together to collectively facilitate innovation, narrow the manufacturing workforce gap and promote sustainable manufacturing ecosystems.

About Flexible Hybrid Electronics (FHE)

FHE gives everyday products the power of silicon ICs by combining them with new and unique printing processes and new materials. The result: lightweight, low-cost, flexible, conformable, stretchable and highly efficient smart products with innumerable uses for consumer, commercial and military applications.

Share




Suggested Items

Michael Carano: A Focus on Process Control, Part 2

09/28/2022 | I-Connect007 Editorial Team
In this second half of our conversation, Michael Carano discusses some of the metrics that fabricators need to consider before investing in new processes, especially process control technologies, and some of the challenges board shops face updating brownfield sites.

A Focus on Process Control, Part 1

09/27/2022 | I-Connect007 Editorial Team
Michael Carano is a noted subject matter expert with respect to process control, electroplating and metallization technology, surface finishing, and reliability. So, it was only natural that we sat down to talk about mechanizing an existing facility given today’s fickle environment. Will any of the CHIPS funding trickle down to bare board fabrication? What process can be adjusted on the factory floor? The focus needs to be more than just on manufacturing and getting work out the door, he says, but also process control.

I-Connect007 Editor’s Choice: Five Must-Reads for the Week

08/05/2022 | Nolan Johnson, I-Connect007
The Top 5 list this week contains industry analysis from IPC’s Shawn DuBravac, news on the passage of the U.S. “CHIPS Plus” bill, new materials from Ventec, news about a fab for sale, and a chemistry company completing their acquisition, plus a brand new book in the I-Connect007 eBooks series.



Copyright © 2022 I-Connect007. All rights reserved.