Author: Monir El Azzouzi
-
Medical Device Software Versioning
Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and […]
-
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.
-
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 devices and how FDA is handling the way to do Post Marketing Surveillance so if you are selling to the US market, check this.
-
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 how you should thing about Risk-Benefit ratio with Naveen Agarwal.
-
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't like it they are expecting your immediate comment as tomorrow is the last day.
-
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 RA should work together.
-
Medical Device News: January 2023 Regulatory Update
All your Medical Device Regulatory update for January 2023 within 30 minutes. Listen to this podcast episode with Monir El Azzouzi
-
Grow your LinkedIn Profile with Karandeep Badwal
If you are looking to grow your LinkedIn profile then you should listen to this episode where Karandeep Badwal will give his learning being part of the LinkedIn Creator Accelerator Program.
-
Is EU MDR extended? with Erik Vollebregt
I know you all heard about the extension of transition period for the EU MDR 2017/745. This is a good news, but let'S understand what this means and how you should interpret all this as there are some misinformation that are spread and we will try to sort out all of them with Erik Vollebregt.
-
MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
If you have a question about the role of a PRRC then most likely this will be answered by one of those expert. This podcast will display the Team-PRRC event where EU commission, Team-NB and BVMed answered the questions of Bassil Akra Board member of Team-PRRC
