Seven entry points into clinical research

by AKRN Scientific Consulting

This article describes seven career paths available to people seeking to break into the field of clinical research.

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Combination products under US FDA regulations and comparison with European regulation

by AKRN Scientific Consulting

​The global market for combination products (i.e., drug-eluting stents, transdermal patches, infusion pumps, inhalers) has been unstoppably growing over the last decade.

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MD or IVD software classification (part II)

by AKRN Scientific Consulting

Under the Medical Device Directive (MDD) and the In Vitro Diagnostic Medical Device Directive (IVDD), medical device software (MDSW) was generally considered to be low risk and, therefore, a low-class...

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COVID-19 – La otra cara: el crecimiento de las empresas biotecnológicas en España

by AKRN Scientific Consulting

El otro lado de la crisis de la Covid-19 pone en evidencia la fortaleza del sector biotecnológico en nuestro país, que sale reforzado

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Preparation is key: brief checklist how to bring IVD MD into compliance with EU IVDR

by AKRN Scientific Consulting

The transition time for In vitro diagnostic medical devices (IVDs) to comply with the EU IVD Regulation 2016/746 (IVDR) is arriving at its end: IVDR will be fully implemented from 26 May 2022. New IVD...

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Partnership agreement with Eupharlaw

by AKRN Scientific Consulting

​AKRN is pleased to announce the partnership agreement with the European Pharmaceutical Law Group – Eupharlaw.

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

by 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

by 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 con...

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

by 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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