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The IVD Product Types: RUO, IUO, GPR, ASR

The Investigational Device Exemption (IDE)

Three Essential Steps to Getting a Device to the U.S. Market

The Safety and Performance Based Pathway

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510(k) ASR CE Marking Definitions Essential Principles Europe FDA Global GPR In Vitro Diagnostics IUO IVD IVDR MD MDR Medical Devices Risk RUO Technical File U.S.
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