CRANSTON, RI – Federal Electronics, a leader in providing advanced electronic manufacturing services, is pleased to announce that its Cranston facility has successfully achieved recertification to ISO 13485. Federal Electronics continues to help life science and medical equipment manufacturers navigate the challenges of complex, competitive markets by offering cost-effective, high- mix, and low-to-medium volume production solutions.
ISO 13485 is an internationally recognized quality management system standard for medical device manufacturers, ensuring that organizations can consistently meet regulatory and customer requirements for safety, quality, and performance. This recertification demonstrates Federal Electronics’ ability to manufacture complex medical electronics systems in a controlled environment while maintaining stringent process controls.
“We take pride in providing best-in-class medical electronics manufacturing solutions, ensuring supply chain confidence and uncompromising quality control,” said Ed Evangelista, President, Federal Electronics. “Our commitment remains steadfast in supporting life science and medical equipment manufacturers with cost-effective, high-quality, and scalable solutions”
With strategic US-Mexico manufacturing operations, the company provides customers with unprecedented cost reductions while maintaining superior quality and compliance. Operating under an umbrella of ISO 9001, AS9100, and ISO 13485, Federal Electronics’ Quality Management System ensures that the company applies a disciplined approach to every facet of the company.
This includes the development of manufacturing, test, and inspection processes; control of non- conforming raw material, WIP, and finished product; supplier management; material and capacity resource planning; employee training and certification; and a robust corrective and preventative action system.
For more information on Federal Electronics and its capabilities, visit www.federalelec.com or contact sales@federalelec.com