Roadblocks Still Exist in Transition to IVD Regulation

Roadblocks Still Exist in Transition to IVD Regulation

It is indisputable that the amending Regulation (EU) 2022/112, which extended the IVD Regulation’s transitional provisions, brought significant relief and protected patients, laboratories and healthcare systems from immediate shortages of needed IVD medical tests. Around 21% of today’s total IVD market is already certified under the IVDR. This represents a three-fold increase compared to July 2021.

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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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