The Wizard 🧙
A brutally simple step‑by‑step guide for getting your MDR compliance done yourself.
No prior knowledge required. One‑time payment.
Unlimited users, lifetime access. 2.999€.
Watch the 7‑minute walkthrough
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.
So we thought: why not build magic software that does teach you compliance?
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 you access here, in your browser. Select a topic on the left, watch the video in the center, and draft the matching template that appears on the right – all in one view.
Achieve MDR certification in record time
Customers have reached QMS and MDR certification using the Wizard inside 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, the Wizard was the perfect choice.
I can recommend the Wizard if you want simple, short, and easy‑to‑understand videos on compliant documentation.
Alexandra Deutschenbaur
Product Manager, Rekoo
We used the Wizard and worked with the amazing OpenRegulatory team to get our medical‑device certification.
We're an early‑stage health‑tech startup and needed guidance while keeping costs low – the Wizard delivered exactly that.
I highly recommend OpenRegulatory’s Wizard!
Robert Wasenmüller
Founder & CEO, Aury
Trusted by fast-moving startups for passing EU MDR audits since over 5 years.
Features
- Proven system: 40+ startups have gone through it.
- No prior regulatory knowledge: It has been successfully used by startups with or without prior regulatory knowledge. If you're lacking regulatory knowledge, the Wizard will teach you.
- Optimised 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 guidance: You'll know exactly what to do because the Wizard shows you the exact order in which you create your documentation.
- Built for startups and fast-moving companies: 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.
- Software as a medical device (SaMD) covered: You'll learn the exact details on how to develop software in a compliant way, also covering agile development and modern software development tools.
- Save 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.
The Wizard
2.999€
One‑time purchase
Get lifetime access for your entire company and take control of your MDR compliance today.
Frequently asked questions
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.
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.
2.999€ as a one-time purchase.
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.
Yes. We don’t believe in per-seat pricing. Everyone in your company can access the Wizard while you only pay one flat price.
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!
Ready To Master MDR Compliance?
Get started and take control of your medical device compliance.
Start watching free videos now, chat with us, or schedule a call.
Got questions? Reach out any time, we're happy to help!