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Completely confused with medical device compliance? No clue what to do next?

No worries, we've got you covered. We've literally done this hundreds of times.

Let's talk and take a look at how you can get this done as efficiently as possible.

We love to help startups, so first calls with us are always free, no strings attached! Book one by clicking the button below.

What the hell do you need to do?

What is a QMS? What is technical documentation? How do we get it done?

Is your software a medical device at all?

Maybe you're not, and that will save you a lot of headaches and money.

MDR medical device classification & class I situation

Get some feedback on which MDR class your product might fall into and whether you might be able to classify it as class I, saving you time and money.

Notified Body (auditor) selection

Unsure which notified body to choose? We'll help you select the best one for your company.

When to hire regulatory people and consultants (spoiler: not now)

When should you bring in consultants like us? Contrary to what you might think, the answer usually is "not now" or "never".

Regulatory software, automation & ChatGPT

Save even more time by automating parts of your regulatory documentation with software.

Do we need to prepare anything?
Glad you asked! Check out this page which answers frequently asked questions. If you come prepared, we’ll have more time to discuss your own questions in our call!
Is it really free?
Yes.
Can we get a demo of your software?
Yes, but that would not be a great use of our time! Instead, check out the video on the Formwork page for a self-guided demo. And then, only ask us specific questions about Formwork in our call, we’re happy to show you how Formwork can solve those, too!
Do you also offer longer sessions?
Only as part of paid consulting projects. That being said, just prepare the 15-minute call well and we’ll likely be able to answer your questions!
Who should join from our team?
People at your company who handle the regulatory work and can influence product and technical decisions.

So, if you’re a team of 3 founders with no employees yet, it might make sense that all of you join. If you’re a larger company, it usually makes sense that one technical person, one product person and the regulatory person joins.

Book free 30-minute consulting call with us below to learn more and get started. It's free, no strings attached!