EU MDR and UKCA on scope
Monir El Azzouzi
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
This week on the podcast we talk about the potential inconsistency that a Notified Body may find. So in case, you are actually drafting your Technical File, this episode is for you. Adam Isaacs Rae is sharing with us some of the issues he has identified so don't miss this.
UKCA vs EU MDR
Last week, Claire Dyson did share with us the situation in the UK related to UKCA. We had a great chat with some tips that medical device manufacturers should follow to be able to stay on the UK market. So don't hesitate to look at it if you are trying to define your UKCA strategy.
Technical Documentation: What is this?
Neelimanair Kallayila did prepare for us a blog post on how to work on your Technical Documentation for EU MDR. This answers most of the questions of Medical Device manufacturers that are still trying to figure out what is a Technical Documentation.
Authorized Representative
If you need an Authorized Representative for EU, UK and Switzerland or if you need an importer for EU or Switzerland, then contact us at Easy Medical Device. We will be able to help you.
eQMS - Scube SmartEye
The move from paper based Quality Management System to electronic QMS is really a big step. Investment on the tool, implementation, support for your Certification.
We are partnering with Scube Technologies to help you make this move really smooth. We create the accounts for you and we act as your Quality Department so no need to hire multiple people for it.
So if you need to create a QMS and integrate it in an electronic tool then contact us as we can help you.