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Life Sciences Blog

Stay updated with the latest insights in life sciences! Our blog explores cutting-edge advancements, regulatory updates, and expert perspectives across pharmaceuticals, biotechnology, and medical devices. From innovation to implementation, discover valuable knowledge to support quality and compliance in the life science industry.

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Life Sciences Blog

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Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations

Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is often mistaken to be the same as Software As Medical...
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CE approval for Medical Devices under MDR: key requirements for your device class

Conformity assessments for CE approval As indicated on the website of the European Commission, a medical device can only be placed on the EU...
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State Of The Art Literature Review – Process and Documentation

A comprehensive, objective, and thorough systematic literature review to describe the general State of the Art and identify all relevant clinical safety,...
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MDR transition: how to plan MDR compliance for your Medical Device?

In June 2022, concerns were expressed that severe challenges related to the implementation of Regulation (EU) 2017/745 on medical devices (MDR) would...
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Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare

Nowadays, regulations on medical devices and medicinal products have very strict expectations on documents outlining the benefits and performance and...
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