The Wizard

🧙
A brutally simple step-by-step guide for getting your MDR compliance done yourself.
No prior knowledge required.

What is it?

Since we brought our regulatory software, Formwork, to market, I've been showing it to many startups.

But there's one problem: Startups don't understand MDR compliance, and they expect compliance software to magically teach them how compliance works. That won't work.

But then we thought: Why not build magic software which teaches you how compliance works?

And now it's done: The OpenRegulatory Wizard.

It has enabled countless startups to achieve their MDR compliance in record time, no consultants (like us) required.

How does it work?

It's a step-by-step video course which you can access in our browser-based software. On the left side, you select the video you'd like to watch. In the center, you see the video. And on the right side, the software already displays the template you need to fill out next.

With the Wizard, people get their MDR certifications done in record time.

Yes, we have customers who have successfully got their QMS and MDR certification with Formwork. You could be next!

Let me try to put our great experience with OpenRegulatory and the Wizard into one sentence: OpenRegulatory transforms norms and regulatory soup into a pragmatic, workable approach.

We got our medical device certification in two months. For us as an early-stage startup with limited resources and aiming for a fast certification, setting up a quality management system and related processes from scratch, OpenRegulatory was a perfect choice.

I can recommend the Wizard if you want simple, short, and easy-to-understand videos how to create compliant documentation for your medical device. If you want things to move even faster, choose the fixed-price consulting, just like we did.

Alexandra Deutschenbaur
Product Manager, Rekoo

We used the Wizard and worked with the amazing OpenRegulatory team to get our Medical Device certification. We’re happy we have come across OpenRegulatory, and would love to work with them again anytime!

We’re an early-stage HealthTech startup and as such, need to be very conscious of time and money. So for the Medical Device certification, our aim was to get effective coaching and guidance on the whole process and on the requirements, while creating most of the documentation ourselves.

I highly recommend working with OpenRegulatory’s Wizard and hiring their team to support you on all things Medical Device!

If you have questions, feel free to reach out to me!

Robert Wasenmüller
Founder and CEO, Aury
And there are more! Here are some companies which used the Wizard.

Features

Proven System
Already 40+ startups have gone through it.
No Prior Regulatory Knowledge Required
It has been successfully used by startups with or without prior regulatory knowledge. If you're lacking regulatory knowledge, the Wizard will teach you.
Optimized for speed and pragmatism
The Wizard videos are not abstract ramblings about regulations. Instead, we show you exactly how to fill out documents as we'll be filling out examples in front of you.
Step-by-step
You'll know exactly what to do because the Wizard shows you the exact order in which you create your documentation.
Focused on startups
This is geared towards startups where a small number of people work on multiple things at the same time and results need to be delivered fast.
Specialized towards medical software (and apps)
You'll learn the exact details on how to develop software in a compliant way, also covering agile development and modern software development tools.
Saves you consulting costs
Will this completely replace consultants? Probably not. But it'll save you a ton of money because you don't have to pay consultants to teach you all the regulatory basics. Instead, you can spend your money wisely on getting specific answers to tricky questions.

Pricing

The Wizard is a one-time, 2.999€ purchase. You get access to the videos in your browser (within our software Formwork). You can invite an unlimited number of users (!) from your company, too. There's no rush because your access doesn't expire. Check out the box on the right side.

Frequently Asked Questions

  • Will I still need a regulatory consultant?

    It depends! We’ve seen some very smart people in startups get everything done themselves with the Wizard. Those people spent ~50% of their time on drafting compliance documentation for 2-3 months, and they also had the time (and nerves) to read the standards (e.g. the ISO 13485). If you have less time (or nerves), you could consider hiring a consultant (us?) in addition to double-check the documents you’re creating.

  • Can we also use this for internal training? Does it generate a PDF certificate?

    Yes! After watching the Wizard videos, you can download a PDF certificate which lists your achievements. You can use that as proof for employee training in your QMS.

  • How much does it cost?

    2.999€ as a one-time purchase.

  • Isn't it a bit expensive?

    Hm, good question! Would I pay 2.999€ for videos as private individual? Probably not. But then again, as a company, our competitors typically price their offerings at 7.000 – 8.000€ while our Wizard actually delivers more value, especially for startups and people who want to get stuff done in a short amount of time. So I still think it’s priced fairly. Also, other consultants sell workshops for around 3.000€ which deliver much less value than our Wizard content-wise.

  • Does it really have unlimited users?

    Yes. We don’t believe in per-seat pricing. Everyone in your company can access the Wizard while you only pay one flat price.

  • Do you offer startup discounts on the Wizard?

    Generally speaking, no. If we go down even further, we’d no longer be able to pay our salaries and put out as much (free) content and templates as we currently do. Still, if you have some financial constraints, reach out and let’s see if we can find a solution!

Still Have Questions?

We're happy to talk! Reach out any time by clicking the button below :)
The Wizard
2.999€
A proven, step-by-step video course for getting your MDR compliance done (79 videos).
Set up a Quality Management System in compliance with ISO 13485
Perform Risk Management based on ISO 14971
Create your Technical Documentation in compliance with IEC 62304
Perform a usability study based on IEC 62366-1
Write your Clinical Evaluation
Optimized for startups
Fast & efficient - save >6 months you'd lose learning this from consultants
One-time purchase, no subscription. Access for unlimited users at your company.
Unlimited users at the same price. And no lock-in: you can export all your data (seriously) and cancel any time.
Review all of the FAQs prior to purchase.
If anything isn't clear, just reach out.