Blog
The OpenRegulatory Blog. If you're tired of regulatory stuff and just searching for entertainment, maybe our blog can be of service? :)
DMEA 2026 Thoughts: DiGAs Dead, More Scribes, Fewer Startups
So we just attended DMEA 2026, which is a large medtech conference in Berlin, and we had a great time! As we're a remote company, it's always great to get...
Why We Share Our Templates For Medical Device Compliance For Free
Here's what happens when I introduce myself to people at Healthcare conferences: "Hello, my name is Oliver, I run a medical device consulting company" At...
The eQMS Graveyard: Enzyme Got Acquired
Back in 2018 (the "stone age of machine learning", as I call it), I got my first job at a medical software startup. We built a machine learning - backed...
Why We're Publishing Our 30-Page EU MDR Roadmap For Free
Today, we're publishing our 30-page EU MDR Roadmap, worth hundreds (thousands?) of Euros, for free. What's the Roadmap? Think of it like a (very) long to-do...
The MDR Is Fundamentally Broken - Our Feedback To The EU
The EU recently asked for feedback on the MDR. Here's what we submitted: While many people here have shared thoughtful feedback, we think that the elephant...
Matrix Requirements Got Sold: Here's What You Need To Know
As a vendor for eQMS software, we talk to potential customers all the time. That gives us an interesting opportunity to learn about new rumors in the medical...
The EUDAMED Files: €9M/Year Budget and a €317K Hosting Mystery
For the first time ever, based on anonymized EU documents we've received, we're exposing the true state of EUDAMED. At the center of it: A gigantic €9M/year...
EUDAMED: Duplicate And Missing Certificates (BEUDAMED November 2024 Update)
Hey! Quick update on the technical situation of EUDAMED: We are screwed 😂 Okay, hold on, let me explain: Building BEUDAMED, a better EUDAMED database, gave...
BEUDAMED: Better EUDAMED
EUDAMED. The idea behind it was so great! Here's the pitch: Instead of 27 medical device databases, one for each EU country, you'd only have one. So if...
The BfArM Processed Our Classification Request, And It Only Took 462 Days
Remember when I wrote about us submitting a BfArM classification request? In the meantime, our request has been processed and we've received the result. It...
You Want To Request Another Free Template? The Answer Is No.
We often get messages like these: “ i need a template for a performance evaluation acc. IVDR ” “ May I have a model post market serveilance plan for Product...
We're Collaborating With BerlinCert, a Software-Focused Notified Body
We've started a collaboration with BerlinCert, a Notified Body which focuses on Software as a Medical Device (SaMD). Why would we do that? Martin Tettke,...
Where Using ChatGPT For Regulatory Documentation Will Fail
A startup recently asked me if they can use Formwork to generate their entire technical documentation with our ChatGPT feature. We haven't built that feature...
Launching Formwork Starter: 49€ For QMS Software And Requirements Management
Update (07/2025): This article is outdated. We've since launched a different Starter tier for Formwork at 99€ / month (not 49€). While that's more expensive,...
The Emergence Of Premium Notified Bodies: 100k€+ For Certifications
If you want to bring software as a medical device to the market under the MDR, it’s likely that it’s class IIa. And if it’s class IIa, you to get audited...
Unlocking Market Access: Navigating Reimbursement Challenges for Medical Device Startups in Europe
In the dynamic world of healthcare innovation, startups developing medical devices face a myriad of challenges, with reimbursement standing as a pivotal...
How MDD Devices Die: Two Case Studies From The Real World
When it came to regulating medical devices, in the past, we had this old thing which was called the MDD. Under the MDD, a lot of software as a medical device...
We're Making Medical Device Compliance 10x Cheaper
Building software products is hard. Very hard. If humanity had some sort of “magic formula” for always creating the right product, then every startup would...
Wise Business Is Great, Unless You Need Access To Your Money: Our Experience
Different people might have different priorities when it comes to business bank accounts. Some people prefer to walk into old buildings where people in suits...
List of Controversial Auditor Opinions
A very-high-up person from a Notified Body recently responded to my LinkedIn post about Notified Bodies sometimes having weird expectations: “Quality of...
Do We Need a Call?
Hey! Thanks for your interest in talking to me. First off, I’m also interested in talking to you! This is not about me trying to make people go away....
Before Our Call: Frequently Asked Questions
Hey there! This article contains our most frequently asked questions. I typically send this around when scheduling calls so that people pre-read it...
DiGAs and the Telekom Cloud Run On Chinese Software From Huawei. Say What?
Okay, let me get a few things straight before starting my rant. DiGAs are great, and creating incentives for building more (Healthcare) tech in Germany is...
Four Problems For DiGA Companies In The Future
Let me start off with this: I think DiGAs are good. The reasoning behind them is good. They bring innovation to an industry which was chronically starved of...
Don't Hire Senior Regulatory Affairs People
So you’ve founded your fancy new medical software startup and realized you’re developing a Medical Device. Great! You’ve also realized that regulatory...
We Got Audited By a Competent Authority. Here's What You Need To Know.
We got audited by a competent authority - the LaGeSo in Berlin to be exact, as that’s where our company is located. Let me tell you how it went and what you...
We're Sending Out Honest Rejections Now
I’ve interviewed a lot of people. When I left my last job in 2020, I counted over 220, and, predictably, that number has increased since OpenRegulatory...
We're Launching Free Consulting
OpenRegulatory started out as an experiment of me brain-dumping my regulatory knowledge to a website. I was like, “well, I’m leaving this field, but it would...
The Great Notified Body Survey
Choosing a Notified Body is one of the most momentous decisions for your Medical Device company. If your auditor is tech-savvy and pragmatic, you’ll be...
No Cookie (Consent Dialogue) For You
Similar to what GitHub pulled off recently, I decided to remove all tracking cookies from OpenRegulatory. Cookie consent dialogues suck. You display a popup...