Omnica Corporation, now a part of StarFish Medical, is a premier medical device design and engineering firm headquartered in Irvine, California. Founded in 1984, the company operates from a 25,000-square-foot facility equipped with advanced in-house machining, model making, and rapid prototyping capabilities. As a contract manufacturer and service provider, Omnica specializes in the end-to-end development of complex medical technologies, including diagnostic products, surgical instruments, point-of-care devices, and monitoring equipment. Their multidisciplinary team of experts provides comprehensive services across industrial design, mechanical and electronics engineering, software development, and regulatory affairs consulting. Holding ISO 13485 and FDA certifications, the company supports a diverse clientele ranging from early-stage startups to global MedTech leaders like Medtronic and Abbott. By integrating with StarFish Medical, Omnica leverages expanded North American resources to deliver specialized R&D, feasibility studies, and seamless transitions to manufacturing for high-technology medical products.
ODM manufacturerProvides ODM design and manufacturing solutions.
Product customizationOffers full customization for design and features.
Established brandFounded in 1984, with over 20 years of industry experience.
Multinational enterpriseOperates in multiple countries or regions like 🇨🇦 Canada, 🇺🇸 United States.
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Regulatory Strategy & Quality Systems
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FDA and ISO 13485-aligned development, design controls, and submission support integrated throughout the product lifecycle.
Medical Device Design & Development
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StarFish Medical’s Irvine office serves as our U.S. development hub and the newest addition to our North American footprint. Located in the heart of Orange County’s MedTech corridor, this site supports U.S.-based companies with local expertise and seamless access to StarFish’s national team of 100+ engineers, regulatory experts, and commercialization strategists. Formerly known as Omnica Corporation, a respected product development firm in Southern California, the Irvine team brings over 40 years of experience in industrial design, engineering, and device innovation. StarFish Medical acquired Omnica in November 2024, integrating its legacy of technical excellence and creativity into a full-service medical device development offering.
Surgical & therapeutic systems
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Our team supports a wide range of devices and technologies.
Medical Device Manufacturing Support
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We facilitate pilot builds, generate comprehensive documentation, and prepare devices for seamless transfer to contract manufacturing organizations (CMOs).
Minimally invasive and Class III medical devices
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Our team supports a wide range of devices and technologies.
Minimally invasive and Class III medical devices
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Our team supports a wide range of devices and technologies.
Optics, imaging, and electro-mechanical platforms
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Our team supports a wide range of devices and technologies.
Surgical & therapeutic systems
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Our team supports a wide range of devices and technologies.
Customers
ABBOTT MOLECULAR
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Certifications
FDA
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FDA Compliance
ISO 13485
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International Organization for Standardization 13485
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Key export market
North AmericaNorth America
🇺🇸 United States🇺🇸 United States
🇨🇦 Canada🇨🇦 Canada
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