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Vitro Diagnostic Medical Device Articles & Analysis

3 articles found

Nanostics Receives CE Mark for its ClarityDX Prostate Test to Detect Clinically Significant Prostate Cancer

Nanostics Receives CE Mark for its ClarityDX Prostate Test to Detect Clinically Significant Prostate Cancer

A CE-IVD Mark is required for all in vitro diagnostic (IVD) devices to be placed in the European Economic Area, Iceland, Norway, and Liechtenstein and allows Nanostics to market and sell ClarityDX Prostate® in these countries. ...

ByNanostics Inc.


What is an IVD Medical Device? Mic Provides a Compact Option

What is an IVD Medical Device? Mic Provides a Compact Option

The global COVID-19 pandemic has spurred on a new demand for diagnostic equipment and products in the race to minimise spread. Airports, workplaces, border checkpoints, hospitals and countless other facilities - they’ve all needed accurate qPCR testing capabilities. ...

ByBio Molecular Systems


Medical Device Regulation - Indian Perspective

Medical Device Regulation - Indian Perspective

The Indian Medical Devices industry is mostly import-dependent with no specific regulations in place till recent times. With the introduction of MDR (Medical Device Rules 2017) attempt has been made to harmonize the Indian medical device Industry as per globally prevailed ...

ByAindra Systems

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