Is an Extractables Study Appropriate for Limited-Contact Devices?

Is an Extractables Study Appropriate for Limited-Contact Devices?

ISO 10993-1 is the cornerstone standard that is broadly recognized and accepted around the world, which is critical if you’re intending to market your device…

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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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