The Wizard
Watch The 7-Minute Walkthrough
What is it?
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?
With the Wizard, people get their MDR certifications done in record time.
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.
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!
Features
Pricing
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!