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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Evidence Partners

How Literature Review Automation Improves CER and PER Program Management

By Marc Dufresne
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Evidence Partners

Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.

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