Richardson Healthcare Announces ISO 13485:2016 Certification

Richardson Healthcare, a Division of Richardson Electronics Ltd., has been awarded ISO 13485:2016 certification. This certification is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.

This certification validates the consistent design, development, production and delivery of medical devices that are safe for their intended purpose. To be certified, Richardson 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,” said 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. The company follows these standards throughout all departments such as customer service, design, manufacturing, assembly and distribution.

“We have invested heavily in our health care 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,” added Edward J. Richardson, chairman, chief executive officer, and president.

With this certification, customers can be confident that Richardson Healthcare is dedicated to maintaining the highest level of quality, efficiency and responsiveness required by the medical community.

Richardson Healthcare will be exhibiting at the upcoming Clinical Engineering Association of Illinois (CEAI) Conference in Oakbrook, Illinois on August 15-16, Booth #210. To schedule a meeting at CEAI, contact Richardson Healthcare at

More information is available online at