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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...
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...
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...
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...
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...
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...
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...
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...
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...
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...