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CE versus FDA registration pathway for medical devices
article
May 31, 2022

CE versus FDA registration pathway for medical devices

Before medical devices may be sold in the EU or the US, they first need to be registered under the CE or FDA mark accordingly.

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The advantages of an AI/ML-enabled search engine for FDA records
article
April 28, 2022

The advantages of an AI/ML-enabled search engine for FDA records

The FDA’s new list of artificial intelligence and machine learning-enabled devices highlights opportunity for improvement.

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How EUDAMED will affect medical device manufacturers
article
March 14, 2022

How EUDAMED will affect medical device manufacturers

EUDAMED provides a living picture of the lifecycle of medical devices

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Key implementation challenges of the Medical Device Regulation (MDR)
article
March 14, 2022

Key implementation challenges of the Medical Device Regulation (MDR)

Major implementation challenges faces EU's MDR

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SaMD - Software as a Medical Device - The Quick Guide
article
March 14, 2022

SaMD - Software as a Medical Device - The Quick Guide

Software as a medical device is attracting attention in the MedTech communities

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