Technical Documentation
Technical Documentation is about describing which features your software has, which risks those features include, and how you do your testing. You also have to do usability (user) testing.
Don't Use Risk Priority Numbers In Your Risk Analysis (ISO 14971)
We recently came across the proposal to include something called "Risk Priority Numbers" in our eQMS software Formwork, and let me tell you, this is a...
Can You Use the OpenAI API In Your Medical Device?
Update (2026/03): I've received some auditor feedback on this topic and updated the article below - I added the auditor opinions at the end. A startup...
How To Do Formative Usability Testing For Medical Devices
So you have a medical device and you want to do formative usability testing, because you have to comply with the IEC 62366, and that's because your goal is...
MDR Examples: Classification Examples for EU MDR Devices
When you're learning new things like the MDR, it's always useful to learn by example, so why the hell are no MDR examples available? So let's go through some...
IFA UDI Hack: Save Money By Using a Health Product Code (HPC)
The business of issuing numbers is probably very lucrative. The big issuing companies like GS1 and IFA charge random prices for their codes. And you have to...
How To Do a Summative Usability Testing For IEC 62366 Compliance
Alright, so you were probably reading the IEC 62366 summary and now you ended up here, wondering how the hell to actually do a summative usability testing...
The IEC 62366 (Usability) Summary: All You Need To Know (It's Not Much)
Oh man, where to start! While probably not much changed for you, as you were happily reading along our Blueprint article and came across this one as simply...
Medical Device Translation: 3 Steps For Medical Device Software
Every now and then, these questions regarding medical device translations come up in our consulting work: • Which device information or parts of the device...
How to Get a UDI (Unique Device Identifier) For MDR Compliance
Here's our guide on how to get your MDR UDI! But first off, if you're actually looking for an overview over the whole topic, check out our overview article...
FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)
Check It Out: Free Video Available While you're gathering your motivation to read yet another article on regulation, let me jump in briefly! We've actually...
ISO 14971 Walkthrough
When developing software as a Medical Device, you need to do Risk Management. What’s that? In simple terms, you need to think about what could go wrong with...
Doing a Software Release in Compliance With IEC 62304
The 62304 doesn’t have many requirements regarding Software Release. They’re mostly about whether you have finished all other activities prior to releasing...
Software System Testing Based on the IEC 62304
The IEC 62304 requires you to do Software System Testing. What’s that? And how does it relate to software verification? According to that article, software...
Medical Device Software Architecture Documentation (IEC 62304)
The IEC 62304 requires you to document your Software Architecture. As always, the standard doesn’t provide many details on how you should actually do that....
Software Verification For Medical Device Software (IEC 62304)
Software Verification is another of those regulatory buzzwords. Unless you’ve worked at an enterprise company before, chances are that you have no idea what...
Writing Software Requirements Based on the IEC 62304
Before we get started: I also uploaded a free template for a software requirements list - have a look! What the Hell are Software Requirements? Software...
Writing Technical Documentation
What the Hell is Technical Documentation? The Technical Documentation (or Technical File) is what you hand in to your Notified Body to get your product...
Writing a Software Development and Maintenance Plan for IEC 62304 Compliance
Check It Out: Free Video Available While you're gathering your motivation to read yet another article on regulation, let me jump in briefly! We've actually...
IEC 62304 Walkthrough
So you’ve decided to develop software which is a Medical Device. Now you need to develop it in an IEC 62304 - compliant way. Resources on how to achieve that...