Autor: Romuald

FDA Committee Befuddled by Data Discrepancies on Paclitaxel Devices

Link


Disruptive AI: Hype or Reality? Where are we on the Artificial Intelligence Timeline?

How close are we to something irreversible? Link


Global harmonization, its work items and clinical evaluation

Nice article for a huge work of GHTF and IMDRF Thank you! Link


Can systems based on AI be certified for medical use?

Can systems based on AI be certified for medical use?


Classification and Qualification of SaMD under MDR

Link


Principles of Labelling for Medical Devices and IVD Medical Devices

I think it will be good to remember for everybody that in March 2019 the IMDRF issued this below document. Link.


How is AI being used in medicine and healthcare?

How is AI being used in medicine and healthcare?


2019 Med Device Trends: Digital Health Will Move Onward

The growth of the role of devices in digital health is No. 5 on a list of developments likely to affect the device industry this year, according to a new white paper, “Top 5 Medical Device Industry Trends in 2019.” Main Link


NAMSA info

In November 2018, CMDE developed draft guidelines regarding clinical trials performed on IVD reagents….https://www.namsa.com/expertise/library/cmde-draft-guidelines-impact-ivd-clinical-trials-reagents/


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