How to use AI GPT for your Quality and Regulatory work?
n this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoi...
5 Syys 20240s
How to go from Zero to Hero in Medical Devices?
In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in c...
27 Elo 20240s
Manage the Transfer/Renewal/Surveillance/Change of your CE certificate
: In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or not...
20 Elo 20240s
How to use Harmonized Standards for Medical Devices?
In this episode, Beat Keller will help you understand Harmonized Standards and how to use them and also how to do when there is no Harmonized Standards. So stay tuned. The post How to use Harmonized ...
14 Elo 20240s
IVDR Class D – Lesson learned from Notified Bodies
TÜV SÜD is one of the main notified bodies. And they are celebrating their 100th Class D certificate. Andreas Stange will explain to us what they learned and how manufacturers can improve their certif...
6 Elo 20240s
EU MDR Major update: Interruption or Discontinuation of supply!
The EU MDR is in constant update and this change on the interruption of supply of medical devices should be integrated. The post EU MDR Major update: Interruption or Discontinuation of supply! appear...
30 Heinä 20240s
How to register your Medical Device in the UAE?
How to register your Medical Devices in the UAE with Ahmed Hendawy from Registitute and Monir El Azzouzi from Easy Medical Device The post How to register your Medical Device in the UAE? appeared fir...
23 Heinä 20240s
EU Battery Regulation – How to be ready?
Medical Devices should follow regulations like EU MDR or IVDR but also some regulations that are also targeting some components like batteries. So for that there is EU Battery Regulation 2023/1542. Er...
16 Heinä 20240s
