Postmarket Medical Device Surveillance at CDRH: Part I

Postmarket Medical Device Surveillance at CDRH: Part I

When a medical device is postmarket, what are the signals FDA CDRH monitors to assess compliance? Learn more about how CDRH assesses these signals.

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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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