ControlTek Receives Renewal of Annual FDA Facility Registration
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.
Establishments that are involved in the production and distribution of regulated medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to register with the FDA. Most manufacturers that are required to register are also required to list the devices and the activities performed on those devices at their facility.
“Start-ups may not be aware of the requirements involved in bringing an FDA regulated medical device to market” said Andy LaFrazia, President of ControlTek. “As a trusted manufacturing partner, we have a responsibility to our customers to maintain robust documentation and quality systems that are enhanced by third party audits. We work hard to bring added value as a manufacturing partner which is demonstrated by our facility registration with the FDA.”
With both design and manufacturing capabilities, ControlTek supports medical device companies with systems and processes that are needed to meet FDA requirements. At ControlTek, that includes manufacturing documentation, supply chain management including critical or custom parts, validation of in-house tools and processes and supporting customer’s in the field.
“We have obtained a high level of competence bringing medical device products to market alongside many successful companies. We love that our commitment to solving the right problem for our customers has led to many lasting partnerships.” -- Andy LaFrazia, President of ControlTek
About ControlTek
ControlTek is a Service Disabled Veteran Owned Small Business (SDVOSB) led by President Andy LaFrazia, Principal Stacey LaFrazia Smith, and VP of Operations Sean Neill. ControlTek is one of the leading electronics design and manufacturing providers in the Northwest. Our experienced staff and impressive range of electronics design, manufacturing, and test capabilities allow us to serve a broad range of industries from consumer products to highly technical and regulated industries including Medical and Aviation/Space and Defense (ASD).
