Best practice for Device Testing with Michael Wetherington
Medical Device Testing is something all medical device manufacturers should perform. How can you prove that your device is safe and performing without that. So now how to do it? Michael Wetherington f...
17 Elo 20200s
Best overview of IEC 60601 for Medical Device electrical equipment
IEC 60601 is one of the most important standard to look at if you have an electrical medical devices. In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situ...
10 Elo 20200s
Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical Dev...
3 Elo 20200s
Learn UDI code for Medical Devices with Sylvia Reingardt
UDI is new for Europe but already exist in the USA. We will explain to you what is important to understand for the EU version as there are some differences. Sylvia Reingardt from GS1 will be my guest ...
27 Heinä 20200s
Understand IEC 62304 for Medical Device Software with Adnan Ashfaq
What is IEC 62304? This is the question I asked Adnan Ashfaq from Pharmi Med Ltd. The answer is helping a lot to understand the interaction with other standards and regulations. Enjoy it! The post Und...
20 Heinä 20200s
How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)
Team-PRRC is invited to this episode to help us understand how to become a PRRC. This is a new role required for Medical Device manufacturers. In this episode, we will also share with you what TEAM-PR...
13 Heinä 20200s
Medical Device News – June 2020 Update
During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say and...
6 Heinä 20200s
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
