KPIs means Key Performance Indicators. This is an important part of the Quality Management System of a company. This is not specific to Medical Devices but you have to have […]
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On this episode of the Medical Device made Easy Podcast I will tell you what are the 6 Types of Medical Device Audits. I know that when you are talking about audit on your companies, there are some kind of Panic Mode. Or maybe you are more "Always Audit ready". So listen to learn more on audits.
The post Episode 6 – What are the 6 types of Medical Device Audits appeared first on Medical Device made Easy Podcast.
2019 is here and as I read many media´s predictions for the medtech industry, I decided to also predicte myself what will be a trend. I will talk specifically about 2 axes which are Technologies and Regulations. Both are linked because as regulators we need to understand the technologies to be able to provide the right answer when we need to issue a regulation.
The post Episode 5 – Medtech Prediction 2019 appeared first on Medical Device made Easy Podcast.
UDI for Unique Device Identification. You will need to understand what is happening with the UDI to be able to implement it. So let´s learn first about the vocabulary.
The post Episode 4 – UDI for Unique Device Identification appeared first on Medical Device made Easy Podcast.
Medical Device made Easy Podcast Episode 3- On this episode I help you to define if your product is a Medical Device in Europe? I know it sounds basic but you´ll see that the new Medical Device Regulation MDR 2017/745 is changing the rules. So listen carefully.
The post Episode 3 – Is my Product a Medical Device in Europe? appeared first on Medical Device made Easy Podcast.
The new EU Medical Device Regulation MDR 2017/745 will be in place by May 26th, 2020 but are you already aware of its content. Listen to this episode to know more.
I provide you some information the timeline for the application of the MDR and also the changes that happen. On the resources, I link to a blog post I created on this topic. And as a gift, I propose you to download an Alexa Skill to tell you how many days remains until the new Medical Device Regulation is live.
Within this first episode of the Medical Device made Easy Podcast I am introducing myself and also this podcast. Don´t forget to subscribe to it so you can be notified when a new episode is released.
The post Episode 1 – Introduction to the Medical Device made Easy Podcast appeared first on Medical Device made Easy Podcast.