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, you might be wondering how our video courses compare to the competition. Glad you asked! Let me draft up a handy comparison table:
| Other Video Courses | Formwork Video Courses | |
| Lecturer & Setting | A person standing up in a well-lit professional studio, often wearing professional attire, e.g. a suit. | A dude sitting hunched over in front of a slightly blurry laptop webcam, sometimes at night with terrible lighting, wearing a hoodie. |
| Length Of Course | Many hours. Takes multiple weeks to watch. | Not many hours. Can be watched in a few days. |
| Depth & Pragmatism | You’ll literally walk through the regulations word-by-word. Afterwards, you’ll still have trouble creating your documentation, but at least you could now become a lecturer yourself. | We walk you through our condensed templates instead and show you how to create your own documentation. You won’t fall asleep. |
I think the table covers the main points. The TLDR is that if you want to get your medical device compliance done in a fast and pragmatic way, choose the Formwork video courses. If you’d like to go super deep for no rational reason, choose our competitors. If you’re unsure, watch some of our free videos and compare yourself before you buy (if you get free samples from our competitors, that is).
Anyway! How does it work?
After clicking on “Courses” in the top bar, you have two courses you can choose from: The Formwork Starter Course and The Wizard 🧙♂️:
Here’s how they compare:
The Starter Course is a 100% free video course consisting of 7 videos. You can watch it in less than an hour. It covers all the frequently asked questions which startups have asked me in my consulting, ever: How long does medical device compliance take? How much does it cost? What do we need to do? Etc.
From experience, people seem to be uniquely unmotivated to watch the Starter Course, but I think that’s not very smart. This investment of less than an hour will probably save you thousands of Euros / Dollars in costs. You’ll avoid common pitfalls like hiring expensive consultants (like us! haha), hiring the wrong regulatory employee (or hiring one at all), over-engineering your documentation, choosing the wrong auditor, etc. All of those mistakes can easily cost you five figures. Anyway, go off and watch it!
Now on to the Wizard.
The Wizard is our paid and complete video course of EU MDR medical device compliance. It does have free videos though if you’d like to take a look! The Wizard really walks you through everything (yes, everything) you need to know for getting your medical device certified under the EU MDR: Setting up an ISO 13485 Quality Management System (QMS), doing your product-based technical documentation as per the IEC 62304, and blah blah, compliance with all the other standards. Check out the Wizard page for more details and pricing.
How Video Courses Work
When clicking on a video course, you’re greeted with, you guessed it, a video:
On the left side, you can view all the videos in this course. Click on one of those to watch another video.
In the center, you see the video. I guess you know how videos work.
Some videos are linked to an OpenRegulatory template. This is actually very cool, because it enables you to fill out your documentation while you’re watching the video. Videos with a linked document are indicated on the left side by having a the title of the linked document underneath them – in the screenshot above, you can see that video 01 (“The Magical Wizard […]”) is linked to the Intended Use document.
You can pop open the document editor by clicking on “Document Editor” in the top right corner (just above the video). Once you do that, the document editor will slide open in a very spectacular fashion:
And off you go, creating medical device documentation!
Again, if you’d like to try it out, many of the Wizard videos are free – click on them on the left side to watch them. If you’d like to purchase the Wizard, click on one of the paid videos. This will present you with a magic blue button which will lead you to the purchase screen for the Wizard.
