Getting Started
If you have absolutely no clue about medical devices and where to start, this is the place to get your started! You’ll learn about coming up with the right classification for your medical device, writing your intended use, accessing standards for little money, and many other exciting things.
Medical Device Accessories
Background: The Case of A Customer A company recently reached out because they received a nonconformity from their competent authority regarding a medical...
MDR UDI: What It Is And How To Get It At GS1 Or IFA
Under the EU MDR, every medical device needs a so-called UDI, which stands for "Unique Device Identifier". The whole scheme has caused a huge amount of...
MDR Class I: Everything You Need To Know
We've posted a lot of stuff on MDR Class I in the past, and this article is my attempt to synthesise all that content into one short, sweet article for you....
People You Need: Person Responsible for Regulatory Compliance and Medical Device Consultants
When you’re becoming a medical device manufacturer in Germany, there are two sorts of people you need. The good news is that you don’t need to employ all of...
MDD Class I: Here's What You Have to Do Before May 2021
I’m currently being approached by many startups who want to bring their medical software to market while the MDR is not yet in effect. So here’s a quick...
Writing An Intended Use for Software as a Medical Device
The Intended Use is the most important document, ever, if you want to certify your software as a medical device. Why? It states what your software does and...
Getting The ISO 13485 And Other Standards For Less Than 30€
You might think that if certain rules apply to all companies of an industry that those rules should be freely available. Like law. Law texts are freely...
How to Classify Software as a Medical Device Under the MDR? (MDCG 2021-24)
Alright! Now the MDR is here and nobody really has any clue on how to classify software. Well, we consultants typically pretend to understand it but the...
Choosing a Notified Body
If you’re anything higher than class I, you need a Notified Body to certify your software as a Medical Device. What the Hell is a Notified Body? They are...
Medical Device Classification
Medical devices are treated differently based on which class they are in. The MDR (EU) and the FDA have different systems of classifying medical devices. We...
The MDR Class I Software Situation
Startups often ask us: Does MDR class I software exist? How does MDR class I software look like? And what features can be included in MDR class I software?...
EU MDR: Step-By-Step Guide To Becoming Compliant
Update (11/2025): We recently our 30-page PDF roadmap for getting your medical device certified under the EU MDR. We used to sell this for thousands of...