MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
The use of certain wording can be a big problem and this is what we will describe here with this MDCG guidance that is not really clarifying the situation but creating more problems. Let us tell you. ...
25 Jan 20220s
How to interview your QA RA Candidates? [Mitch Robbins]
What is your method to perform an interview? You are not trained as a recruiter so how should you do to interview a QA RA Candidate. This is what Mitch Robbins will explain to you on this episode. So ...
18 Jan 20220s
How to accelerate your Laboratory Test Results? [Christoph Lindner]
Lab Tests can be really tricky for the success of your Medical Device Design. We will help you in this episode to understand with Christoph Lindner. Check show notes for more details. The post How to ...
11 Jan 20220s
Medical Device News – January 2022 [Happy New Year]
HAPPY NEW YEAR 2022! Another year passed and this went really fast. But the Medical Device News is still here. So today we will talk of all the releases done in December 2021 and what is planned for t...
4 Jan 20220s
What happened in 2021? Summary for the Medical Device Industry
I know, already the end of 2021. So many things happened that this may be difficult to summarize. So I've tried to put my TOP information on this episode. I also share with you the new projects for Ea...
28 Dec 20210s
The Step-by-Step recipe to get MDR & IVDR Certified
For this christmas season, I wanted to summaries the situation on how to get MDR & IVDR certified. So i made this step-by-step recipe where you just need to follow. I hope you'll enjoy. The post The S...
21 Dec 20210s
Which devices cannot be Custom-made? [Erik Vollebregt]
If you are not aware, the EU MDR 2017/745 is completely changing the definition of Custom-made devices and this is mainly what we will try to explain to you on this episode. If you still have some que...
14 Dec 20210s
Medical Device News: December 2021 Regulatory Update
Here is the last Medical Device News for this year, I will cover all the updates that happen in the EU, UK, Switzerland,, US and Saudi Arabia. We will also review the situation for Notified Bodies. I ...
7 Dec 20210s
