Tag Archives: regulations

Romuald Braun, Amplexor
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Smart IDMP: How to Ensure Preparations for ‘Data-Driven’ Future Are a One-Time Investment

By Romuald Braun
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Romuald Braun, Amplexor

EMA’s IDMP is not the pinnacle of data-based product/regulatory information management. It is simply the first in what will be a long line of digital requirements to emerge globally, across all facets of life sciences. This article reviews best practices for companies looking to maximize the ROI of their data-driven process transformation initiatives by making them more broadly fit for the future.

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EU Device Regulations – What’s Changing and What Will Be The Impact?

What’s changing in the medical devices and in vitro diagnostic regulatory landscape in the European Union, and how can you effectively navigate these changes? This article offers an overview.

What’s changing in the medical devices and in vitro diagnostic regulatory landscape in the European Union, and how can you effectively navigate these changes? This article offers an overview.

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Worldwide Medical Device Regulatory Updates

By Stewart Eisenhart
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As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.

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