Prepare your transition from Class I to Class Ir
In this episode, Tautvydas will share with us its experience with Manufacturers that tries to move from Class I to Class Ir for Reusable Surgical Instruments. Don't miss it if your company is on scope...
28 Helmi 20230s
SaMD international reach – What to consider?
The Global reach can be a problem when we talk about Medical Device. This is mainly what we will discuss with Stéphane Berger as he is trying to put globally is Software as a Medical Device in differe...
21 Helmi 20230s
Biological Evaluation: Top Big mistakes
If you need to perform a Biological Evaluation for your Medical Device, Paul and Laura from Icare Group will be the best partners for you. Check the advice they provide. The post Biological Evaluatio...
14 Helmi 20230s
Medical Device News: February 2023 Regulatory Update
Your Medical Device News is ready for the month of February 2023. This is containing some information on the extension of the EU MDR timeline so don't miss it. The post Medical Device News: February 2...
6 Helmi 20230s
How to do Post-Marketing Surveillance in the US (vs EU)?
Post marketing Surveillance for medical devices in the US market is done differently than in EU. So learn on this podcast how to be prepared with Rob Packard. We will talk about multiple sort of devic...
31 Tammi 20230s
How to evaluate Benefit-Risk Ratio for Medical Devices?
You maybe arrived to this section of the Techniocal File asking for Risk Benefit Ratio and you don't know what to write on it. On this episode we will explain to you what are your possibilities and ho...
24 Tammi 20230s
Breaking News: EU MDR Extension Proposal is out for consultation
You asked for the extension of the transition period for MDR? Then you have the proposal for the change. Now the question is if you are satisfied and if the content is helping you? No worry if you don...
17 Tammi 20230s
How to improve the relationship between QA – RA and Marketing?
Let's see if you can improve relationship between your industry departments and Quality and Regulatory affairs. We will talk about that with Omar M. Khateeb who will explain to us how Marketing and QA...
10 Tammi 20230s
