IRVINE, Calif. and TUSTIN, Calif., June 27—DeviceLab Inc., an Orange County medical product design and product development company, hosted a company exhibit booth at the Orange County Regulatory Affairs’ Appreciation Night earlier this month at the Irvine Marriott.
OCRA is a non-profit volunteer organization comprised of regulatory affairs professionals from the Southern California area that are interested in participating in educational programs and networking with one another. Membership includes individuals that work in life sciences industries such as medical devices, pharmaceutical, biologics, IVD, dietary supplement, food, cosmetics and more.
“As a medical device design company, it’s crucial that we are privy to the latest FDA medical device regulations to ensure compliance for the complete medical product development solutions that we offer our customers, and our membership in OCRA helps us achieve that,” said DeviceLab Vice President–Operations Le Bui.
DeviceLab offers a suite of medical product compliance services that relate to risk—including risk evaluation, risk control, and risk analysis based on IEC 60601 (third edition)—as well as medical product software verification and validation framework development.
OCRA also helps DeviceLab foster key relationships with Orange County medical product regulation experts, said Bui.
“Our region has an outstanding reputation for medical device innovation and development, and these events truly help underline that notion,” said Bui. “As a member of the OCRA, events such as Appreciation Night affords us the opportunity to not only enhance our expertise in designing medical products that meet FDA requirements, but also to engage with the Orange County medical product regulation community.”
DeviceLab is an ISO 13485-certified contract medical device design and product development firm in Orange County, California.
A full-service company, DeviceLab has expertise in mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. The company has considerable experience in design and development of tabletop and hand held devices, custom medical carts, hospital equipment and lab instrumentation development.
For more information about DeviceLab, please visit www.devicelab.com.