FDA approved electronics manufacturers

Custom Electronics Manufacturing and Design Services provider, ControlTek, is a designated Service Disabled Veteran Owned Small Business (SDVOSB) led by President and retired Lieutenant Colonel Andy LaFrazia.  

VANCOUVER, WASHINGTON, December 17th, 2020: ControlTek receives renewal for their annual facility registration with the FDA. As a medical device manufacturer, the registration supports ControlTek’s adherence to Current Good Manufacturing Processes, or CGMP. 

Medical manufacturing is one of the fastest-growing manufacturing industries, but it’s certainly not without unique challenges.

At ControlTek, our entire design engineering, project management and contract manufacturing teams are all highly experienced with the often complex requirements as identified by the FDA.

From initial research and development to testing and documentation, ControlTek’s services can provide assistance at any stage of your medical device development. Our FDA registered facility and ISO 13485 certified quality system provides an audited environment that meets FDA requirements and includes services such as medical electronic design (circuit, mechanical, PCB layout and more), product and pcb prototyping, and test design.

From design requirements to FDA approval, the experts at ControlTek have continuously exceeded my expectations. Partnering with ControlTek has assisted in making RS Medical a definitive provider of electrotherapy devices.

- Mike McGraw, VP, RS Medical
www.rsmedical.com