Tag Archives: EU MDR

Romuald Braun, Amplexor
Soapbox

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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National Cancer Institute

Cybersecurity by Design in Medical Devices

By Dr. Abtin Rad
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National Cancer Institute

Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.

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