Richardson Healthcare, a Division of Richardson Electronics, Ltd., LaFox, Ill, has been awarded ISO 13485:2016 certification, which is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
The ISO certification validates the consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. To become certified, Richardson Healthcare demonstrated the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
“Quality is at the core of Richardson’s long history, and this ISO certification represents our continued commitment to that tradition,” says Pat Fitzgerald, Executive Vice President and General Manager of Richardson Healthcare.
As part of the ISO certification process, Richardson participated in a thorough audit of its quality system processes, as well as product quality requirements, which are standards the company follows throughout all departments, including customer service, design, manufacturing, assembly, and distribution.
“We have invested heavily in our healthcare manufacturing facility and are proud of the team’s accomplishment. We are able to incorporate many of the ISO13485 best practices throughout the rest of our manufacturing operations making Richardson Electronics that much stronger in both the CT and power grid tube industry,” adds Edward J. Richardson, the company’s chairman, CEO, and president.
In addition to providing high-value diagnostic imaging replacement parts, tubes, equipment, and technical support to hospitals, diagnostic imaging centers, medical institutions, other ISOs, and more, Richardson Healthcare offers a wide variety diagnostic imaging components and systems, as well as robust in-house manufacturing capabilities. In addition, the company provides CT-service training and complete post-sale service and support, including installation, maintenance, troubleshooting, calibration, and conformance.