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Kathryn Kukulka Email
Director Regulatory Affairs . Omnica Corporation - Product Development
Irvine, CA
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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 specialty is custom product development for the medical industry and industrial fields. Our expertise is developing complex medical devices. Technical personnel at Omnica includes industrial designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers. The client determines the scope of our involvement. Depending on the their requirements, we can handle everything from concepting the initial idea, performing the design and engineering, prototyping first articles and sourcing appropriate manufacturers. The projects we develop range from disposables/consumables, hand-held instruments and surgical devices to monitoring equipment, laboratory instruments, diagnostic products and point-of-care devices. Our resources and personnel enable us to be especially capable at developing technically complex projects that require six to eighteen months for completion. Virtually all development, design, and prototyping are done on the premises with our employees, tools, and resources. Our technical staff is familiar with FDA documentation and has experience in designing for compliance with most regulatory standards including CE, UL, TUV, and Quality Systems Regulations. Ongoing project documentation procedures include accurate, detailed record keeping at every step in the development cycle.Omnica Corporation - Product Development Address
15560 Rockfield Blvd.Irvine, CA
United States