Hiring or looking for a job in Digital Health? Check out our Digital Health Jobs board

Articles Blog

October 24, 2023

We're Making Medical Device Compliance 10x Cheaper

Dr. Oliver Eidel

Building software products is hard. Very hard.

If humanity had some sort of “magic formula” for always creating the right product, then every startup would become a success and build a product people love.

But we don’t have a magic formula.

In reality, startup failures vastly outnumber startup successes, and building the “right thing” is an elusive event onto which people mostly stumble upon by accident.

Even big tech companies are not immune to this. They also produce more failures than successes - look at the huge (and growing) list of products which Google stopped working on. How many commercially successful products has Google launched, besides Ads? The answer is somewhere between “not many” and “none”.

So - building the right product is hard. If that product is software, it is even harder. That’s because developing software is expensive and slow, and it therefore becomes more likely that you run out of money, or time, or both, before shipping at something people love.

Now, if you’re in the medical device industry, you’re even more screwed, because developing a product which is both software and a medical device hits you with even more required time, and more costs.

A substantial chunk of those costs, and your required time, is determined by the consultants you hire for medical device compliance.

Medical Device Compliance Costs

Before we entered the market, a good rough estimate of consultant costs was this: For a typical MDR class IIa software device, consultants would charge you around 120-150k€ for helping you, and together with them, you’d need around 12 months to set up your documentation before being able to hand it in to an auditor.

The elephant-in-the-room question here is: Why the hell does it take so long, and why the hell is this so expensive?

Most consultants reply to this by noting that “setting up a quality management system is always unique to a company, and your company is so unique”. This, in my opinion, is an attempt to exploit founder’s weaknesses in furthering their belief that, oh yes, their company is so unique.

It is not.

Startup reality is different. Most three-person software startups are more similar than they are different.

Accordingly, setting up medical device documentation for small software startups, to a large degree, is mostly about copy-pasting templates and making minor adjustments to them. It is a process which is very similar across companies, it can be repeated, and it can be optimized.

Headstart: 50% Cost Reductions, Fixed Price

This lesson lead us to two things: Firstly, we started offering our templates for free, so that startups can already get a lot done themselves - if they have time.

And if they don’t, we started offering our Headstart consulting package which cut down the cost by a factor of 2 (50-70k€ instead of 100-150k€) and time by a factor of 4 (2-4 months instead of 12 months). We also made it a fixed-price offer which gives startups back full cost control, in contrast to other consultants who charge by the day.

Four times faster, two times cheaper. But does it work?

Yes, and our success proves us right. We’ve worked with 100+ clients in the meantime, and their products are on the market in less time, for less money.

But can we go even further?

Yes. Today, we’re launching Formwork All-Inclusive, which cuts down consulting costs not by a factor of four, but by a factor of ten.

Formwork All-Inclusive: Medical Device Compliance, 10x Cheaper

You see, we also sell our eQMS Software, Formwork. Even though it’s software, the proposition here is surprisingly similar to our consulting: It’s simpler, faster, and cheaper than everything else out there.

One of our Formwork customers, Akina, recently got their QMS certificate in 7 months. That’s an insane success!

So - our consulting is faster, and Formwork makes companies faster yet again. That got us thinking: What if we combine them?

We think the efficiency gains are pretty huge. But the cost reductions might be even more surprising: We think we can bring the consulting cost down by 10x.

That’s why, today, we’re launching Formwork All-Inclusive. It’s a subscription at 1.999€ / month which includes Formwork and consulting. Here’s how it works:

How It Works

  1. You sign up for Formwork All-Inclusive and get full access to Formwork and our Wizard videos (included!).
  2. You watch the Wizard videos and create drafts of your documentation, based on our templates.
  3. We review your drafts, reply to your questions, schedule weekly calls if you like, and finalize your documentation (all included!).
  4. Once you’re done, you downgrade your subscription to a “normal” Formwork subscription - less costs, no more consulting required.

Sounds interesting?


Right now, we’re limiting Formwork All-Inclusive to one client. Yes, one. That’s because we’re still testing the model and, quite honestly, it’s also a risky proposition for us as we’re forgoing 50-70k€ in consulting revenue in exchange for 2k€ subscription revenue.

If you’re interested, fill out this form. Applications are open for the next few days and we’ll select a client by Nov 3rd, 2023.

Frequently Asked Questions

Can I move away from Formwork later?

Yes! In contrast to all other eQMS software out there, there’s no lock-in with Formwork and you can export your data any time and move to another eQMS system, or even git or Google Drive.

Can I get this without Formwork?

No. The whole idea to improve efficiency is to combine our consulting with Formwork.

How long will this run and much will it cost in total?

Depends on how fast you are. Our best clients get this done in 2-4 months, and then you could downgrade your subscription. One aspect is that this will definitely incentivize you to get stuff done quickly, haha..

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

Congratulations! You read this far.

Get notified when we post something new.

Sign up for our free newsletter.

Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!


If you have any questions or would like to share your opinion publicly, feel free to comment below. If you'd like to reach out privately, send us a message.

No QMS on this planet will save you from creating crappy software.