How to perform a good Clinical Investigation with Helene Quie
Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consulting...
15 Juni 20210s
How to perform a Biological Evaluation for your Medical Device?
This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biol...
8 Juni 20210s
Medical Device News – June 2021 Update [EU MDR Date of Application]
Medical Device News June 2021 Update is providing you all the last updates. This IS the episode of the EU MDR date of application. A lot of news provided. The post Medical Device News – June 2021 Upd...
1 Juni 20210s
EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]
EU MDR is starting tomorrow and we wanted to check the situation for Economic Operators. We had already interviewed Catherine on the previous survey release. This time we do a follow-up The post EU MD...
25 Maj 20210s
MDR is coming so brace yourself with Erik Vollebregt
1 week to the EU MDR and we hope that you are ready. If not, then you can maybe listen to this episode as we are answering some last minute questions. The post MDR is coming so brace yourself with Eri...
18 Maj 20210s
FDA: Is the Emergency Use Authorization worth it? (EUA)
This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott on ...
11 Maj 20210s
Medical Device News – May 2021 Update [EU MDR 2017/745]
This is the last month before the EU MDR 2017/745 Date of Application. We will talk about that and about all the updates The post Medical Device News – May 2021 Update [EU MDR 2017/745] appeared first...
4 Maj 20210s
Checklist – What is important before the EU MDR Date of Application?
It is Day -30 for the EU MDR date of application. So let's summarize what should be ready for you and also what is not mandatory. The post Checklist – What is important before the EU MDR Date of Appli...
27 Apr 20210s
