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 P

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

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 dont miss this if you plan an FDA appli

You are not manufacturing the product you are selling. Can you be EU MDR certified? The post You are not the Physical Manufacturer, can you be MDR certified? appeared first on Medical Device made Easy

Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You’ll see that this is so diverse. […] The post MEDICA 2023 &#

The extension of the EU MDR and IVDR created some misunderstanding and in this episode, I invited Pritam from TV SD to help us understand when to apply to a Notified Body, the cost of it, the expect

Medboard Who is Medboard EU  EU Reference laboratories EURL Letter to EU Parliament  Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/

A Heatmap is a visual representation of data where values in a matrix are represented as colours. Lets review with Stefan Bolleininger how this may help Regulatory Affairs departments. The post Regul

Easy Medical Device has its podcast and many other Quality and Regulatory Affairs people are also doing podcasting. I have met with Claudia and Jorg who are also having a podcast and we reviewed our e

To be able to sell products in different countries, you need to understand what are the requirements for each of them. This is where the Regulatory Affairs department is helping. In this episode we wi