How to sell Medical Devices online in the EU and US?
If you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherin...
22 Mars 20220s
What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
If you are not sure of your Clinical Evaluation, then maybe by listening that you will have a better understanding of what is expected from you. So don't miss the lesson learned with Cesare Magri The ...
15 Mars 20220s
Why do we need the Common Specification for Class D IVDR?
You will hear more and more about IVDR and now we talk of the Draft Common Specification. Have a look at the explanation from Andreas that will help you be more efficient if your products are on scope...
8 Mars 20220s
Medical Device News – March 2022 Regulatory Update
This month the big news is about FDA amending QSR to integrate ISO 13485. Not sure on how this will be at the end but it's always cool to have harmonization. No worries, other topics like IVDR, MDCG, ...
1 Mars 20220s
Why would you need a Swiss Authorised Representative and Importer?
What is the role of a Swiss Authorized Representative and Swiss Importer? And most importantly why would you need one? I'll tell you everything on this podcast episode. The post Why would you need a S...
22 Feb 20220s
How to be great at Management Reviews? [ISO 13485]
Management Review is one of the most important activity to perform before to be ISO 13485 certified. So today I will explain to you how to be great at it. The post How to be great at Management Review...
15 Feb 20220s
Why Design History File (DHF) is so important? [Alexandros Savvidis]
DHF is an accronym that people don't really understand and in this episode Alexandros Savvidis he tries to help us have a view of his experience. The post Why Design History File (DHF) is so importan...
8 Feb 20220s
Medical Device News: February 2022 Regulatory Update
All the February 2022 updates on MDR and IVDR, Clinical requirements and some news on the guidances and Notified Bodies. The post Medical Device News: February 2022 Regulatory Update appeared first on...
1 Feb 20220s
