Richardson Healthcare is stepping up its reputation as a quality manufacturer with the obtainment of ISO 13485:2016 certification.

To hold the international standard provides greater confidence to customers by validating the ability of the healthcare division of Richardson Electronics Ltd. to design, develop, produce and distribute medical devices that are safe for use, particularly in its manufacturing of CT solutions and power grid tubes.

"Obtaining certification to ISO13485 demonstrates to our customers and to regulatory bodies that we have an organization that is committed to the Medical Device Industry and we have the discipline to maintain the structure we have created to run an efficient business with a focus on quality, regulatory compliance and customer expectations," Pat Fitzgerald, executive vice president and general manager at Richardson Healthcare, told HCB News. "Our Quality Management System allows us to ensure our product meets specifications as we operate with well-defined, controlled and documented processes."
Obtaining the honor was dependent on Richardson’s ability to demonstrate that it could develop and distribute medical solutions and related services that continually met customer and regulatory requirements.

To do so, the enterprise participated in a thorough audit of its quality system processes and product quality requirements, exercising these standards throughout all of its departments, including customer service, design, manufacturing, assembly and distribution.

Its bestowal is the second piece of news surrounding Richardson in the last three months, following the company’s unveiling in May of its new replacement tube for Toshiba CT systems.

The granting of ISO 13485:2016 to Richardson is expected to ensure increased trust from its customers in its ability to maintain the highest level of quality, efficiency and responsiveness in accordance with the medical community’s needs and standards.

"Over the next few years, we expect to see more global harmonization of quality and regulatory related standards," said Fitzgerald. "We anticipate increasing demand on manufactures, service providers and parts distributors to demonstrate compliance to quality system standards. We believe the end goal should be to ensure products on the market are safe and effective without driving up the cost of healthcare by imposing overly restrictive requirements."

The company is set to hold its first exhibit under its new certification this week at the Clinical Engineering Association of Illinois (CEAI) Conference in Oakbrook, Illinois.

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