Articles
Practical guidance for medical device teams navigating compliance, quality systems and regulatory strategy.
Top 7 AI Prompts To Automate Your QMS (MCP)
So we shipped an MCP server to our eQMS software, Formwork, just recently, and here I'd like to share some prompt ideas. Feel free to steal them and 100x...
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...
Matrix Requirements Alternative: What Companies Choose
Here's the backstory: Matrix Requirements, a QMS software company, got sold to a private equity fund in around 2024 (which I wrote about here). Shortly...
Dot Compliance Alternative: Better Fits For Faster-Moving Teams
If you are looking for a Dot Compliance alternative, here's the TLDR: Dot Compliance is the right choice for you if you love setting money on fire and enjoy...
MasterControl Alternative: Better Options For Medical Device Startups
If you are looking for a MasterControl alternative, here's the TLDR: MasterControl is the right choice for you if you love setting money on fire and enjoy...
SoftComply Pricing: Confusing (Just Like Jira)
Here's what I saw when researching SoftComply pricing. Let's just say that their website team might need to put in some work regarding site reliability:...
MasterControl Pricing: Beyond Crazy
The eQMS industry is a weird industry. On its surface, eQMS software is not very complex - at the end of the day, what you get is a "Google Drive with...
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...
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...
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...
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...
Clinical Evaluation Report: Literature Search - SaMD
Clinical Evaluation Report: Literature Search for Software as a Medical Device You managed to identify risks, the software requirements are defined and...
FDA Risk Classification for Software as a Medical Device (SaMD)
The Food and Drug Administration (FDA) plays a vital and hands-on role in the United States, ensuring medical devices are safe and effective before they ever...
The Medical Device Product Development Journey: A Phase-by-Phase Guide
So, you have an idea for a medical device? Awesome! But how do you get from that "aha!" moment to a finished product that's safe, effective, and compliant?...
Design History File (DHF) for SaMD: Your Software's Design Story
Developing Software as a Medical Device (SaMD) is a complex process. Throughout the software development lifecycle – from the initial concept and...
Creating Turtle Diagrams for MDR & FDA Compliance
In the highly regulated world of medical devices, demonstrating robust process control isn't just good practice – it's a regulatory necessity. Both the EU...
Electronic Case Report Form - FDA vs. MDR
If you're in the medical device field, you know that clinical studies are often essential to prove your device is safe and does what it claims. This is...
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...
SimplerQMS Pricing: Starts At $1,200
Let's look at the SimplerQMS pricing today, as SimplerQMS is a rather new QMS software out there. Call it "rather new" is a bit ironic, because one auditor...
eQMS Data Models: Hard-Coded Entities vs. Flexible Entities
Besides all the ranting I usually do in this website, today I (surprisingly) had a constructive idea for an article. This is one of those "I wish someone had...
Is Your Medical Device Safe? Understanding Biological Evaluation
Medical devices, from simple bandages to complex implants, are designed to help patients. But how do we ensure they don't cause harm when they interact with...
Authorised Representative For Non-EU Manufacturers
As a manufacturer based outside the European Union (EU) and without an EU subsidiary, you must appoint an Authorised Representative (AR) to market your...
The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR
Manufacturers of medical devices need to set up a quality management system (QMS). However, the details of this set of SOPs and templates vary between the...
Medical Device Codes: EMDN, UMDNS, GMDN and MDR
Once you embark on your regulatory journey towards CE certification, you will inevitably come across the strange land of medical device codes. It's not...
OpenRegulatory Sustainability & Governance: Will We Be Around 5 Years From Now?
Some companies ask us how "safe" it is to trust us, OpenRegulatory, when using our eQMS software. After all, you're entrusting us with your medical device...
FormlyAI Pricing: Not Good For Startups (2026 Update + Dovetail)
Update (2025): Formly has removed its transparent pricing table and now only offers bespoke, "contact sales" individual pricing (sadly). See below for the...
How to Document Separate Medical Device Software Components
Let's assume your software has various different components - and you have no clue how to separate medical device software components from other, non-medical...
QT9 Pricing: Costs, Contracts, and Uncertainties
Here's all we know about the pricing of QT9's QMS Software. QT9 offers an array of quality management modules, and while their product offerings are more...
QMS Quality Manual: Quality Policy and Quality Objectives
You are just starting to set up your QMS quality manual? When setting up your QMS, this is one of the first documents slammed at your face. You describe your...
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...
Matrix Requirements Pricing: Huge Price Increase, 2026 Update
What's the Matrix Requirements pricing like in 2026? The company made multiple significant changes to its pricing structure, and multiple customers of ours...
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...
Support Us: Link To OpenRegulatory
We spend a lot (a lot!) of our time working on stuff which we end up giving away for free - our free medical device (MDR) templates, the free tier of our...
How To Purchase Formwork With The Startup Discount
Update (March 2025): We've changed Formwork's pricing. The good news for you is that the discounted price of 499€ (instead of 799€) is now available to...
Greenlight Guru vs. Qualio: QMS Software Comparison
Greenlight Guru vs. Qualio - which QMS software is better? Both Greenlight Guru and Qualio are QMS software providers, and both target the medtech / life...
EUDAMED: How To Use It, And Why It Sucks
When the MDR came into effect, the European Commission also started building EUDAMED, which should server as a central database for all medical devices...
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...
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...
Dot Compliance Price (QMS Software)
Here's all we know about the pricing of Dot Compliance's QMS Software. Dot Compliance offers multiple products in the compliance space. While their product...
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...
Software (And Hardware) Test Runs in Formwork
So you want to learn about Software (or Hardware) Test Runs. So the first distinction here is that these are test runs, not the actual tests. A quick table!...
Software (And Hardware) Tests In Formwork
After you've documented some of your Software Requirements in Formwork, you now probably want to document some Software Tests. Why? Because the IEC 62304,...
Software Requirements (And Design Inputs) In Formwork
Managing your software requirements is probably one of the activities you'll spend your most time on. So what the hell are software requirements? In short,...
The Formwork Manual
Everything you need to know about our eQMS software, Formwork. Quite a few of articles below are still in progress - you'll notice this if they aren't...
Creating QMS Records in Formwork
Let's take a look how you create QMS records in Formwork. As a quick reminder, your QMS in Formwork has two types of "things": Documents and records. In...
Thanks For Booking Your Free Consulting Call!
Hey there! Thanks for booking a call with us! :) To make the most of your call, I've collected some frequently asked questions here. If you read them and...
Formwork eQMS Pricing, And When You Should Upgrade
One common question is when you should upgrade your Formwork subscription, and whether you lose data if you change your mind and downgrade. Let's take a...
Documenting Your Medical Device In Formwork
You want to document your medical device product in Formwork. Great choice! You probably don't know this yet, but choosing Formwork will save you a gigantic...
IVDR Requirements: What You Need To Become Compliant
The Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR) sets the framework and requirements for - obviously - diagnostic medical devices....
Reviewer Roles In Formwork
In Formwork, you can send out various "things" for review: Documents, Records and Change Requests. The common theme with all of these is that you don't...
Creating QMS Documents In Formwork
Let's see how you can manage your QMS documents in Formwork. First off, what's the difference between documents and records? In short, documents are...
Managing Your QMS In Formwork
So you want to set up your Quality Management System (QMS) in Formwork. Alright! When clicking on "QMS" in the top bar, you are greeted with this friendly...
Video Courses In Formwork
So you want to learn more about medical device compliance. Cool! The Formwork video courses are your best resource for accomplishing just that. First off,...
Getting Started With Formwork
Ah yes, you've finally gathered the courage to sign up for an eQMS software and deal with this whole messy affair of regulatory compliance for your medical...
How Do We Ensure the Post-Market Surveillance Under the IVDR?
Question: We are a manufacturer of in-vitro diagnostic medical device software. How do we ensure the post-market surveillance under the IVDR? Short answer:...
Thanks For Booking Your Formwork Demo Call!
Hey there! Thanks for booking a Formwork demo call with us! :) To make the most of your call, I've collected some frequently asked questions here. If you...
Thanks For Booking Your Call!
Hey there! Thanks for booking a call with us! :) To make the most of your call, I've collected some frequently asked questions here. If you read them and...
Clinical Evidence for In-Vitro Diagnostic Medical Devices
Clinical evidence - What is this? Clinical evidence for in-vitro diagnostic devices (IVDs) is gathered through performance evaluations, assessing scientific...
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...
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...
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....
One of those Bugs a Software Engineer lives for
Recently, while working on Formwork I came across one of those bugs that a Software Engineer lives for. What do I mean by that? It was very complicated,...
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...
IVDR Classification: Classification Of In-Vitro Diagnostic Devices
In this article, we'll walk you through the basic IVDR classification concepts for software as an IVD and look at some examples. The Regulation (EU) 2017/746...
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,...
Software Validation: How To Do It (Pain From Hell)
Let me just start by saying that I think software validation is complete crap and an utterly unnecessary activity invented by regulators and bureaucrats....
Qualio Price: What We Know So Far
If you're looking for eQMS software right now, you might be wondering what the Qualio price is. Don't worry, you're not alone! We've worked with 150+...
Greenlight Guru Price: Crazy increase (12/2025 update)
Update (12/2025): We've talked to a few customers who told us that Greenlight Guru is significantly raising their prices starting in 01/2026. They...
Qualio Alternative: Don't Make This Mistake
Qualio is a popular QMS software, and many consulting customers ask us if we know of any Qualio alternatives. The problem with Qualio often is that it's...
Greenlight Guru Alternative: Enterprise Software Mistake?
Update (04/2026): We've successfully migrated a few companies away from Greenlight Guru and have updated this article with our experiences accordingly....
IEC 62304 PDF Download
You're probably looking for a free PDF download for the IEC 62304, the standard for software development for medical devices. If you're looking for a short...
IEC 62366 PDF Download
You're probably looking for a free PDF download for the IEC 62366, the standard for risk management for medical devices. If you're looking for a short...
ISO 14971 PDF Download
You're probably looking for a free PDF download for the ISO 14971, the standard for risk management for medical devices. If you're looking for a short...
ISO 13485 PDF Download
You're probably looking for a free PDF download for the ISO 13485, the standard for quality management for medical devices. If you're looking for a short...
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...
All You Need to Know About QMS Software
What the hell is QMS software, and do you need it? And how do you learn more about QMS software without falling asleep or being bombarded by sales calls from...
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...
Post-Market Surveillance: The Ultimate Guide under MDR
Okay, you managed the ISO 13485 certification, walked through endless discussions with your notified body and finally you can put the CE sticker on your...
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...
The True Shadiness Of QMS Software For Medical Devices
If you want to bring a medical device to market, it’s likely you’re also looking for QMS software. And if you have no idea what any of those things are, then...
QMS Software for Medical Devices (ISO 13485): Comparison
Updated in 09/2025 with new QMS software providers; also updated prices in 06/2025 as many providers of QMS software for medical devices have raised their...
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...
No, Telemedicine Software Is Not Class IIa Under The MDR
How is Telemedicine software classified under the MDR? If you’re in Hamburg, the answer might be class I, class IIa, or not at all, depending on who you ask....
Free QMS Software: Google Drive, SharePoint, GitHub, GitLab
So your company works in a regulated industry (like medical devices, what we specialize in) and you have to set up a Quality Management System (QMS) for...
ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes
KPIs are like scorecards for organizations, helping them track how well they’re doing and if they’re moving closer to their goals. In the world of ISO 13485...
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...
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...
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...
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...
Brace for Impact: The New MDR Transition Periods
Brace for Impact: The New MDR Transition Periods It has been much discussed and we covered it in our newsletter before: now - drum roll - the MDR deadline...
Time Zones in Rails
We received this message some months ago: “Hi! I just added the Intended Use document in Formwork. I noticed that the time stamp is wrong (15:07 instead of...
Automating Medical Device Compliance With QMS Software: Can you eQMS the pain away?
In medical device manufacturing, ensuring product quality, safety, and regulatory compliance are of paramount importance, but they also cause paramount pain....
Clinical Evaluation
In simple terms, your Clinical Evaluation is a rather lengthy document which looks a lot like a Bachelor’s thesis (yup). Its main goal is to show that your...
July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
I hope you’re having a great summer! Things have quieted down here in Berlin, besides the usual subtle chaos of manufacturers and auditors trying to find out...
Open Source QMS Software Overview: GitLab As QMS?
I recently googled “Open Source QMS Software” and one of the top results actually was a page on SourceForge. That made me realize that I’m old. Do you...
Supplier Management Under ISO 13485:2016
Let’s look at how to perform supplier management under the ISO 13485:2016. Effective supplier management is critical for controlling risks, ensuring the...
Maybe Harmonized Standards Are Becoming Freely Available Soon
Let’s start off my quoting my 30-year-old self, in the depths of the pandemic of 2020, unemployed and ranting about standards: “You might think that if...
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...
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...
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...
How We Keep Your Formwork Data Safe
Many companies ask us how we keep their data in Formwork safe. That’s a very reasonable question because you’re entrusting us with very important data which...
Is Formwork an Enterprise Software? Does It Have [Enterprise Feature X]?
Some of the people interested in Formwork expect Formwork to be an enterprise eQMS software, with all the associated features. They would send me an email...
Setting Up a Quality Management System (QMS) in Google Drive
Software for Quality Management Systems can roughly be divided into two categories. You can either purchase specialized regulatory software which has...
Clinical Evaluation: How to Write a Regulatory Compliant Literature Review
A clinical evaluation is required for all medical devices according to the MDR. The main task of a clinical evaluation is to identify pertinent data in...
GitHub QMS: We No Longer Recommend It
While I wrote up a rather balanced post on the pros and cons of using GitHub / GitLab as your QMS software, I’d like to follow this up with our combined...
Enterprise QMS Software: Don't Waste Your Money
So you’re looking for enterprise QMS software for your medical device compliance, and you’re wondering which software to choose. You’ve checked out a few...
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...
What Is QMS Software, and Do You Need It?
Since we launched our own QMS Software, I’ve been approached a gazillion times by companies who wanted to buy it and requested a demo - many of them wonder...
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...
Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps
When certifying software as a medical device (or any medical device, really), you need a Clinical Evaluation. If I had to sum it up in one sentence, the...
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...
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....
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...
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...
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...
Setting Up a Quality Management System (QMS) in GitHub / GitLab
Update: We no longer recommend using GitHub / GitLab as your QMS software. I wrote down our thoughts in a separate post (read it here) because I didn’t want...
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...
100.000€ Spent and Never Done (Fail)
I meet many startups working on Healthcare software. They all have their own consultant stories to share. Unfortunately, those are often failures. The...
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...
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...
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...
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...
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?...
CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?
So, when you start out on your exciting (yes) regulatory journey, pretty early on you’re going to come across the word “CAPA”. Seasoned regulatory...
ISO 13485
The ISO 13485 is the standard for quality management in the medical device industry. This page is a collection of all our articles on this quality management...
IEC 62366
The IEC 62366 is about usability of medical device software. In practice, it’s mostly about running usability tests with users. This page is a collection of...
IEC 62304
The IEC 62304 describes how to develop and document software for medical devices. This page contains all our articles we’ve posted so far on this standard,...
ISO 14971
ISO 14971 is the standard for risk management of medical device software. This page is a collection of all our articles on risk management. We also publish...
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...
Generate Your Technical Documentation Automatically: Formwork Audit Export
Starting today, Formwork can automatically generate your Technical Documentation. This is really exciting and can save you a lot of time. View the video...
Using Formwork as a Regulatory Consultant
Prior to launching Formwork, we did a lot of regulatory consulting. It always was our goal to be a profitable company, and doing consulting helped us bring...
Copying Records is Tedious.. Not Anymore!
Copying records is tedious. What do I mean by that? The documentation of your medical device software contains many records. Examples for records are your...
No Lock-In, Ever: Formwork Batch Export
When we built Formwork, we had two goals: 1. Don’t be evil. 2. Don’t suck. While this may seem obvious for any software product in a free-market economy, it...
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...
The IVDR Might Require 264 Notified Bodies
Happy New Year! We had some restful holidays and I hope you did, too. Here's our first newsletter of 2022 with some IVDR news and minor template updates....
ISO 13485 Amendment, Templates, User Manuals
Quite a few regulatory things have happened recently! Before we wrap up the year, let's take a quick look. We'll be off starting next week, so happy holidays...
MDR Classification Chaos and User Manuals
Hey you, we've published some new articles about regulatory stuff and the things we do. The first one is about the not-so-helpful new MDCG 2021-24 regarding...
FBE GmbH: Solving Problems and Reviewing Documents For Less Than 2.000€
Imagine you’re a small company developing software as a medical device. Your software is done (nice!), and you’ve created some documentation. But now you’re...
OpenRegulatory Newsletter #1: Conference
First off, why the hell are you getting this email? Simple: You signed up for our newsletter at openregulatory.com and probably forgot about that. That's my...
Exakt Health: MDD Class I Compliant in 3 Months
Let's look at Exakt Health - because if you’re a Healthcare startup developing software as a medical device, you’re probably wondering: How long does it take...
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...
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...