You are not the Physical Manufacturer, can you be MDR certified?
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...
23 Tammi 20240s
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…
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 – InterviewS w...
18 Tammi 20240s
WARNING! APPLY TO YOUR NOTIFIED BODY NOW!
The extension of the EU MDR and IVDR created some misunderstanding and in this episode, I invited Pritam from TÜV SÜD to help us understand when to apply to a Notified Body, the cost of it, the expect...
16 Tammi 20240s
Medical Device News – january 2024 Regulatory Update
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/TXT/PDF/?uri=CON...
10 Tammi 20240s
Regulatory Maturity Model – Heatmap (MEDICA 2023)
A Heatmap is a visual representation of data where values in a matrix are represented as colours. Let’s review with Stefan Bolleininger how this may help Regulatory Affairs departments. The post Regu...
2 Tammi 20240s
Life of QA RA Podcasters?
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...
26 Joulu 20230s
Why should you invest in your Regulatory Team?
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...
18 Joulu 20230s
What is Usability for Medical Devices?
The usability is a term that seems complicated but within this episode Michael Engler we will try to explain to you in simple terms how you can succeed within your project. So don’t miss this episode ...
12 Joulu 20230s
