#339: UDI and the State of EUDAMED

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere ...  Show more

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for tal ...  Show more

Rome was buzzing with digital health at the end of May as the HIMSS Europe conference took place at La Nuova Congress Center. Delegates from 80 countries and representatives of health ministries of 20 countries marked the event with discussions about the implementation of EHDS, t ...  Show more

It's an important year for the European Union, which holds parliamentary elections in June. As geopolitical turbulence continues to test the strength of global alliances, will Europe pursue further integration or start to pull apart? Gideon discusses these questions, and the r ...

According to WHO, the global cost associated with medication errors is 42 billion US dollars. Errors can happen at the point of prescribing, transcribing from one system to the other, or administration, when the wrong patient is given either the wrong drug or the wrong dose. Medi ...  Show more

In this episode of Monster Under the Bed, we bust the idea that the EU is something to scare people with, and the myth that it costs us too muchIn the last few years, the EU budget has become a major topic of public discourse – whether in the media, or in our neighbourhood cafes. ...  Show more