Medical Device made Easy Podcast

On this episode, Steve Curran from Trinzo will help us understand how to be better at doing your Postmarketing Surveillance. The post How to do Postmarketing Surveillance the right way?  appeared fir...

19 Mar 20240s

On this episode, Naveen Agarwal will explain to us the consequences for the alignment between QMSR and ISO 13485. The post Learn more about FDA QMSR alignment with ISO 13485 appeared first on Medical...

12 Mar 20240s

EU Training Services ROW USA CANADA Mexico Saudi Arabia Qatar Australia PODCAST EASY MEDICAL DEVICE Services: The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device...

6 Mar 20240s

The recent Proposal on Medical Device shortage, EUDAMED Timeline and IVDR transition is discussed and the question is will this become law. The other question is, Do we think this will change somethin...

27 Feb 20240s

EtO is one the widest methodology used to sterilize medical devices. So what is the consequence if the EtO gaz is now considered as a Medical Device? The post Will EtO gaz become a Medical Device?  a...

20 Feb 20240s

The preparation for your interview is important this is why I have invited Elena Kyria from Elemed to help us. The post How to get your interview prepared? appeared first on Medical Device made Easy ...

13 Feb 20240s

This month we'll talk about the updates in EU and the rest of the world. The IVDR extension, the MDCG guidances, the language requirements, the trainings, events, podcast... ALL ALL ALL. Check that no...

7 Feb 20240s

In this episode, Saad will be explaining to us what Q-Sub or Pre-Submission by the FDA is. And why this may be your Superpower before you submit to the FDA. So don’t miss this if you plan an FDA appli...

30 Jan 20240s