Does the MDR mean the end of the equivalence route for clinical evaluations?

por AKRN Scientific Consulting

In Europe, medical device manufacturers with products on the market have long used clinical data from equivalent devices to confirm the clinical safety and performance of their devices. Using clinical...

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The importance of registering and posting clinical trials in a public database

por AKRN Scientific Consulting

Clinical investigations, commonly referred to as clinical trials, play a pivotal role both in developing new treatments and in detecting, diagnosing, and reducing the progression of disease conditions...

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List of Notified Bodies under IVDR (EU) 2017/746 on In-Vitro Diagnostic Medical Devices

por AKRN Scientific Consulting

A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is a process by which you demonstrate that the produ...

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