Develop Compliant Medical Software.

Learn how to solve regulatory compliance efficiently without setting your hair on fire.

And get back to building your product.

Because that's what matters.

Know These Companies?
Now You Know Us.

Ada Health
Alex Therapeutics
AI Medical
BabyCare
DeepPsy
Dermadigital
DoMore Diagnostics
Exakt Health
Fimo Health
Floy
Headacy
Healthcaters
iCat
Imvaria
Kranus Health
Line Systems
MedxAI
Mindpeak
Noah Labs
Nostos Genomics
Novoic
Onqo
Oxaigen
Panakeia
Perifit
Physikit
PreciPoint
Pregive
Promaton
Radiotherapy AI
Rekoo
Selfapy
Tensorscope
Therapy Lift
Tomedo
Una Health
Vara
Vila Health
x-cardiac
Xenco Medical
Zollsoft
Ada Health
Alex Therapeutics
AI Medical
BabyCare
DeepPsy
Dermadigital
DoMore Diagnostics
Exakt Health
Fimo Health
Floy
Headacy
Healthcaters
iCat
Imvaria
Kranus Health
Line Systems
MedxAI
Mindpeak
Noah Labs
Nostos Genomics
Novoic
Onqo
Oxaigen
Panakeia
Perifit
Physikit
PreciPoint
Pregive
Promaton
Radiotherapy AI
Rekoo
Selfapy
Tensorscope
Therapy Lift
Tomedo
Una Health
Vara
Vila Health
x-cardiac
Xenco Medical
Zollsoft
Read our Case Study how we enabled Exakt Health to ship their physiotherapy app in just 3 months!
And here's our other Case Study how we helped FBE ship their app, BabyCare.

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Who Are We?

We're three dudes who are passionate about helping Healthcare startups enter the market.

Oliver is a medical doctor and software developer. He founded OpenRegulatory in 2020 after leaving his job at Vara, where he helped get the first AI-based software approved as a medical device.
Sven's background is in political sciences. He worked at IBM Watson before and knows way more about quality management systems and data privacy than Oliver.
Sören is a Pharmacist with great enthusiasm for technology and innovation. He's got lots of experience in software development documentation, risk management, usability engineering and data privacy.
More about us

Recent Updates

December 2, 2022

Setting Up a Quality Management System (QMS) in Google Drive

Software for Quality Management Systems can roughly be divided into two categories. You can either purchase specialized regulatory software which has specific features for whatever regulated industry you’re in, or you can choose a generic software and attempt to re-purpose it as your regulatory software.

Read more

December 2, 2022

Should You Do a BfArM Classification Request? The Answer Is No.

Question

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December 2, 2022

Template: SOP Sales

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December 2, 2022

We Got Audited By a Competent Authority. Here's What You Need To Know.

We got audited by a competent authority - the LaGeSo in Berlin to be exact, as that’s where our company is located. Let me tell you how it went and what you need to know if you ever run the risk of getting audited by one (which is.. always, if you’re a medical device manufacturer in the EU). And, by the way, this probably is the first public report of a competent authority audit, ever. Cool!

Read more

Why Do Startups Fail?

Regulatory compliance can be so easy. But most startups don't get it and fail.

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