Patient Dies, and the FDA Issues Warning Letter to In-Vitro Diagnostic Medical Device Manufacturer | Wilson Sonsini Goodrich & Rosati – JDSupra

Patient Dies, and the FDA Issues Warning Letter to In-Vitro Diagnostic Medical Device Manufacturer | Wilson Sonsini Goodrich & Rosati – JDSupra

Recently, the U.S. Food and Drug Administration (FDA) issued a warning letter to Luminex Corporation. Luminex "manufactures microsphere-based and [polymerase chain reaction] PCR-based…

Sourced through Scoop.it from: www.jdsupra.com

Who We Are

Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.

Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.

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