Omega Depot Regulatory Intelligence

IVD & Laboratory Kits

Diagnostics, RUO products, reagents and kit logistics.

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IVD & Laboratory Kits

IVD, RUO or Chemical: Classifying Laboratory Kits

Is the kit an IVD, RUO or a chemical? Which regulatory regime the intended-use claim triggers, how the GTİP is chosen and how the import file is built.

Laboratuvar kitleri ve reaktiflerRUO etiketli araştırma ürünleriGenel kimyasal preparatlar ve tanı amaçlı kullanılan materyaller
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IVD & Laboratory Kits

Biological Samples and Temperature-controlled Kit Logistics

How biological samples are packaged, how temperature-controlled kits are shipped and how reverse logistics is recorded. The moving half of the diagnostic chain.

Biyolojik numune taşıma ve paketleme hizmetleriSıcaklık kontrollü kit sevkiyatlarıNumune geri lojistiği ve saha toplama materyalleri
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IVD & Laboratory Kits

Multi-component Kit Classification and Documentation

Is the kit as a whole or its components classified, how are multi-vendor components documented and how is the set declaration built? The file rules of multi-component kits.

Çok bileşenli tanı kitleri ve setleriFarklı üreticilerden bileşen içeren setlerKitlerle birlikte teslim edilen yazılım ve sarflar
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IVD & Laboratory Kits

Reagents, Calibrators and Control Materials

What the statuses of reagents, calibrators and control materials determine, how traceability is proven and how the import file is built. The three legs of the diagnostic chain.

Tanı amaçlı reaktifler ve preparatlarKalibratörler ve metrolojik izlenebilirlik materyalleriKontrol materyalleri ve iç kalite kontrol ürünleri
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IVD & Laboratory Kits

IVDR Scope and Risk Classes

Where IVDR scope begins, how risk classes A to D are determined and how the class shapes conformity assessment. The class map of diagnostic products.

In vitro tanı cihazları ve kitleriPerformans değerlendirme ürünleriTanı amacıyla kullanılan yazılım ve aletler
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