A brutally simple step-by-step guide for getting your MDR compliance done yourself.
No prior knowledge required.
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 don't understand how regulatory software can help them achieve it.
Instead, they expect a magical tool that miraculously makes them compliant.
So we thought: Why not build that tool?
And now it's done: The Formwork Wizard.
Dr. Oliver Eidel
Managing Director and Soccer Mom at OpenRegulatory
Introducing the Formwork Wizard.
A predictable, self-guided step-by-step program
for startups to become MDR-compliant.
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.
The Wizard, in combination with the free OpenRegulatory templates, did a great job of breaking the complex standards and regulatory language down into easy-to-understand, actionable points. The Wizard videos provided explanations and examples to understand the regulatory requirements, explained what exactly the templates cover, as well as how to fill them out.
In addition, we chose the fixed-price consulting of OpenRegulatory to guide us through the process even more efficiently. Not being billed by the hour, we had the feeling that our project was not made unnecessarily long or complex, and together we could adjust it to our time and deadlines. The team was always available and gave quick and valuable feedback after reviewing our documents.
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 OpenRegulatory Videos (part of their 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. Of course, it was not an option to compromise the documentation quality, and we were looking for real experts in the field of Medical Device certification.
I can confidently say that this was the right approach for us – it worked out really well and saved us tons of time and money. And I can’t emphasize enough that OpenRegulatory is the best partner for this pragmatic certification approach. Why I’m so sure about it:
- The OpenRegulatory videos can be used by real beginners (like myself), are super to-the-point and specific, guiding you through the whole process of filling out your documents
- OpenRegulatory actually enables you to understand and do things yourself in no time
- As you can imagine, the cost is just a fraction of what you would have paid working with consultants 1:1 throughout the whole process – while the results will be the same or better compared to a traditional consulting process
- I was looking for alternatives but haven’t found a single one
- Last but not least, the videos are even fun to watch and it felt kind of easy “riding along” with them and filling out the documentation :-)
I highly recommend working with OpenRegulatory’s Videos, Wizard and hiring their team to support you on all things Medical Device!
If you have questions, feel free to reach out to me!
During our consulting, we noticed that most of the stuff we do is highly repetitive: We're pretty much explaining the same documents all the time. This sucks because it's boring for us and inefficient for our clients.
We asked ourselves: Can it be automated? Like, an automated consultant?
And the answer is yes!
The Formwork Wizard is like an automated consultant which explains you how to create your documentation. It's much cheaper than a "real" consultant and you can work at your own pace.
On the right side, the Wizard gives you a document editor with one of our templates preloaded in it. On the other side, the Wizard displays a video in which we explain how to fill out the document.
Each step in the Wizard is short and easy to follow - typically, videos are somewhere between 5 and 12 minutes in length.
The Wizard covers compliance for ISO 13485, IEC 62304, ISO 14971 and IEC 62366. Additionally, there are videos for BfArM product submissions.
The Wizard is a one-time purchase of 1.999€. You get lifetime access for unlimited users for your company - yes, that's right, we don't have per-seat pricing. That means you can invite all your colleagues to go through the Wizard.
You can purchase the Wizard now and get access right away! 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".
After registering on Formwork, navigate to Settings - Billing.
Proven System
Already 20+ 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.
Yes, probably. But it's very likely that you'll save you a ton of money because you don't have to pay a consultant to teach you all the regulatory basics. Instead, you can spend your money wisely on getting specific answers to tricky questions. I like to say that the Wizard gets you 90% there, and the 10% are tricky and often need a human consultant. A bit like creating tax returns with software.
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.
1.999€ as a one-time purchase.
Hm, good question! Would I pay 1.999€ for videos as private individual? Probably not. But then again, as a company, our competitors typically price their offerings at upwards of 5.000€ while our Wizard actually delivers more value, so I still think it's priced fairly. Also, other consultants sell workshops for around 3.000€ which deliver less value than our Wizard.
Yes. We don't believe in per-seat pricing. Everyone in your company can access the Wizard while you only pay one flat price.
After registering on Formwork, navigate to Settings - Billing.
What's in the box
IEC 62304
Software Development
The IEC 62304 is about documenting your software and establishing processes which ensure that your software development is compliant. Among other things, that includes documenting your software requirements, software tests and libraries (SOUP - software of unknown provenance).
ISO 14971
Risk Management
To be compliant with ISO 14971, you need to perform a risk analysis of your device, as well as establish risk management processes in your company.
IEC 62366-1
Usability Engineering
The main chunk of work for IEC 62366-1 compliance is performing usability tests with users. With those, you prove that your product is actually usable.
ISO 13485
Setting Up Your QMS
Sven shows you how to set up your Quality Management System (QMS).
MDD
Medical Device Safety Officer Training
For the old legislation in Germany (MDD / MPG), you needed a so-called Medical Device Safety Officer. That person needs to have an idea of what his/her obligations are. You can use these videos to teach yourself and create a PDF certificate.
MDD
Medical Device Consultant Training
Similar as the Medical Device Safety Officer, the MDD / MPG had a requirement for so-called Medical Device Consultants. Typically, those are your salespeople and people in customer support. They also need to be trained.
Germany / BfArM
BfArM Registration
For one of our customers, we brought a medical device to market. That gave me the unique opportunity to walk you through the process of navigating the slightly confusing BfArM / DIMDI registration system!
After registering on Formwork, navigate to Settings - Billing.