Regulation

Views on the rules and regulations that govern medical technologies.

Regulation

Posted on 29.01.2020

The changing EU regulatory landscape: CE Marking for Medical Technology

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Regulation

Posted on 19.08.2019

The increased role of Clinical Research Organizations in the context of the new EU regulations on medical devices

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By Șerban Marius Roșu, Associate Professor of Medicine and Pharmacy, University of Timişoara

Regulation

Posted on 29.07.2019

Local and regional authorities are central in the European debate on health

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By Valentina Polylas, Operations Manager at EUREGHA

Regulation

Posted on 05.07.2019

Are you ready for Eudamed?

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By Lionel Tussau, Director Business Development, Atrify

Regulation

Posted on 02.07.2019

From here to 2024: personalized medicine for an immediate future

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By Denis Horgan, Executive Director, European Alliance for Personalised Medicine

Regulation

Posted on 15.05.2019

A bold new vision for the medical technology community

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By Eric Thépaut, Senior Vice President and President, EMEA - Boston Scientific

Regulation

Posted on 13.05.2019

IVDR: an overview of clinical evidence requirements

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By Peter Rose, Managing Director, Europe - Maetrics

Regulation

Posted on 13.05.2019

Notified Bodies are becoming a regulatory bottleneck

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By Fabien Roy, Partner - Hogan Lovells

Regulation

Posted on 24.04.2019

Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing

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By Prof. Dr. Folker Spitzenberger, Professor at the University of Applied Sciences, Luebeck, Germany

Regulation

Posted on 08.11.2018

The fog of war: crunch time in the regulatory cycle

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By Ronald Boumans, Senior Regulatory Consultant at Emergo

Regulation

Posted on 02.10.2018

IVDR: The designation issue during the transitional period

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By Stefano Dettori, Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)

Regulation

Posted on 18.09.2018

The ‘nanny state’ and the case for health literacy

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By Denis Horgan, Executive Director, European Alliance for Personalised Medicine

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