The secrets to being EU MDR certified with Shokoufeh Khodabandeh
Shokoufeh from Straumann in Switzerland is sharing with us her journey on the EU MDR world. She will tell us what helped the team to reach this success and what she would have changed. The post The se...
29 Kesä 20200s
How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)
Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not fol...
22 Kesä 20200s
How to execute your Internal Audits? (Medical Device companies)
In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it. The post How to execute your In...
15 Kesä 20200s
Medical Device News – May 2020 Review with Monir El Azzouzi
The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG, Not...
8 Kesä 20200s
What means Sufficient Clinical Data with Bassil Akra (EU MDR)
Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak. Bassil Akra from QUNIQUE Group will explain to you w...
1 Kesä 20200s
What is the Notified Body situation? (Bassil Akra from TUV SUD)
If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this. The post...
25 Touko 20200s
How to get ISO 13485 certified? (Quality Management System)
I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read. The post How to ...
18 Touko 20200s
How to get your Digital Health Application reimbursed in Germany? (DIGA)
You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you change yo...
11 Touko 20200s
