Ana Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed duri...

EUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, ...

Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of th...

The MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an ...

Are you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is The...

We have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IV...

Maybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequence...

On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don...

There are a lot of questions about Software as Medical Devices. So I have invited Dr. Abtin Rad from TÜV SÜD to give us more information about how to ...

This is a question I asked myself when I started my career. I am now an independant consultant but I started as a Full-time employee. So Smahan will h...