EmbedTek LLC Registers with FDA as Medical Device Contract Manufacturer

EmbedTek, LLC, a technology company specializing in the design and manufacture of embedded computer systems, software, sensors, and displays, today announced it has registered with the U.S. Food and Drug Administration (FDA) as a Contract Manufacturer of Medical Devices.
 
Registered contract manufacturers manufacture a finished device to another establishment’s specifications. For EmbedTek customers, this means that EmbedTek has the ability to take on all responsibility for the manufacture and direct shipment of medical devices, in some cases accepting joint responsibility for the quality of the finished product.
 
“We have been ISO 9001 and ISO 13485 registered for many years and we fully embrace the responsibility to provide high-quality devices to our customers,” said Dan Aicher, Chief Executive Officer of EmbedTek. “FDA registration adds an additional layer of commitment and responsibility to our organization to ensure the consistent safety of the devices we manufacture.”
 
EmbedTek registered with the FDA as a result of its partnership with a leading manufacturer of innovative surgical imaging systems. The partnership has grown over multiple years with EmbedTek providing computing, visualization, mechanical, electrical, and other design and supply chain support. EmbedTek engaging as the contract manufacturer of the complete device is the next step in expanding that partnership.
 
Medical equipment manufacturing is the fastest-growing segment of the EmbedTek business, according to Aicher. EmbedTek has new engagements with several additional medical equipment original equipment manufacturer (OEM) partners that are seeking advanced embedded technology capabilities combined with complete manufacturing and delivery services.
 
“Medical OEM customers appreciate the combination of creative engineering, integration, and supply chain management provided by a company that lives and understands the regulatory requirements of FDA-registered contract manufacturers,” said Aicher.
 
The entire process of design, manufacturing, and integration happens under one roof at EmbedTek’s facility in Pewaukee, Wisconsin. In addition to ISO 9001 and 13485 certifications, the facility is equipped with an ISO 14644-1 Class 6 (FS209 Class 1000) cleanroom, shock and vibration environmental chamber, 3D printing capabilities, effective electrostatic discharge (ESD) controls, and lean cellular manufacturing.
 
“EmbedTek’s registration with the FDA is an exciting milestone that will undoubtedly lead to unique and challenging opportunities for us and for our current and future customers,” said Jeff Hampe, Quality Manager for EmbedTek. “While we maintain a mature and effective Quality Management System to comply with the national and international standards and regulations applicable to our business, our success also stems from our ability to leverage the QMS to add value for our customers. I’m extremely fortunate to work with a talented and professional team that is exceptional at accomplishing both.”