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Confused about UDIs? Learn how they work and how to get yours.

We literally purchased real UDIs for these videos!

“I have attended the video course entitled "Understanding UDIs" by OpenRegulatory, available on Formwork. The course provided a very clear explanation of a complicated topic in a very simple and didactic way, and the content was very informative. The outline of the course website was also very clear, and I got the certificate right away. The instructor was enthusiastic and knowledgeable. Highly recommended.”

Diana Rosentul
Regulatory Specialist at Aiosyn

Why?

The theory of UDIs is great - "let's create some sort of way to uniquely identify medical devices, like with barcodes!".

But the implementation is a catastrophe. You have to purchase UDIs from different vendors with ancient IT systems and opaque pricing models. And even if you manage to purchase your UDI, it's very complicated to understand what the hell your UDI-DI, UDI-PI and Basic UDI-DI are, because every vendor has different names for them.

It's a mess.

How does it work?

We recorded videos for you to show you how you can get it done easiy. This is not an abstract video course on theoretical ramifications of UDIs. Instead, it's hyper-concrete as we literally purchase UDIs ourselves to show you how the system really works.

Watch Us How We Purchase UDIs

Yes, we literally purchased real UDIs for this video course. This is as concrete as it gets. You'll watch us how we purchase UDIs from GS1 and even create a label for our imaginary medical device. After this, you'll know what to do. Watch the video below to see how that works.

How Much Does It Cost?

The UDI course is a one-time purchase and included in our Wizard video course which costs 2.999€. The Wizard course also contains videos on all other topics to help you bring your medical device to market, you should check it out!

How Can You Get Access?

You can purchase the UDI course now and get access right away! As the UDI course is integrated into our Wizard video course, you simply purchase the Wizard and also get access to the UDI videos. To purchase: If you don't have a Formwork account, register now, then head over to the the course section, select the Wizard, navigate to a paid video and click "purchase".

Ready to Get Started?

After registering on Formwork, navigate to Courses, select "The Wizard" and click on a paid video to purchase.

Register and Purchase Now

Still have questions?

If you have any questions, reach out any time!

Get in touch

Features

Frequently Asked Questions

Which UDI providers are covered in the videos?

We currently cover GS1, but we're working on videos on IFA.

Will I still need a regulatory consultant for UDI support?

No. After this video course, you'll be able to set up your own UDIs.

How much does it cost?

2.999€ - it's part of our Wizard video course, and that's the price of it. It's a one-time purchase.

How many users can access the video, and for how long?

You get access for unlimited users, i.e. for your entire company as we don't believe in per-seat pricing. Access is not time-limited, so you won't be in a rush to watch the videos.

Ready to Get Started?

After registering on Formwork, navigate to Courses, select "The Wizard" and click on a paid video to purchase.

Register and Purchase Now

Still have questions?

If you have any questions, reach out any time!

Get in touch

What's in the box

List of All UDI Videos

Getting Started

You'll learn what the hell a UDI is and why you need it.

Getting UDIs at GS1

You'll learn how to purchase your UDI at GS1, a popular UDI provider, step by step.

10:59

Registering at GS1 and Purchasing a UDI

Free - click to view
10:14
How to Use The GTIN Manager
03:12
Creating The Basic UDI-DI As GMN
10:35
UDI-PI and Barcode With Application Identifiers

Getting UDIs at IFA

IFA is another large company from which you can purchase UDIs. We walk you through how to do it.

07:22

Introduction to Getting a UDI From IFA

Free - click to view
09:04
Registering As a Customer At IFA
05:23
Hack: UDI-DI for Free with HPC
07:09
Ordering a PPN via Auftragstabelle B3
02:28
Generating the Basic UDI-DI
04:59
Creating UDI-PI and Data Matrix Code

UDIs and EUDAMED

The final step is registering your UDI an EUDAMED, the EU medical device platform which is uniquely hard to use.

15:15
Registering Your UDI at EUDAMED

Ready to Get Started?

After registering on Formwork, navigate to Courses, select "The Wizard" and click on a paid video to purchase.

Register and Purchase Now

Still have questions?

If you have any questions, reach out any time!

Get in touch
No QMS on this planet will save you from creating crappy software.