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May 2022


Threat modeling – An introduction

By Prof. Dr. Christian JohnerMay 23, 2022Leave a comment

Threat modeling is a “mandatory” topic for all manufacturers of medical devices that contain or are software. This is because threat modeling is a structured process for the systematic analysis of IT security risks that auditors consider to be the “state of the art.”

Performing FDA recalls correctly

By Luca SalvatoreMay 17, 2022Leave a comment

If a medical device does not (or no longer) meets the FDA’s requirements, manufacturers, distributors, and importers must recall it. This applies in particular if the device presents a hazard. In this article you will learn,

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