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.

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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 and one dudess 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.
Nicoleta's background is in Pharmaceutical Sciences, and she did her PhD in computational modeling. She likes to bridge the gap between early-stage start-ups and the market.
More about us

Recent Updates

September 29, 2022

Template: Document Roadmap for Technical Documentation

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September 29, 2022

Template: Software Architecture Checklist

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September 29, 2022

Template: Software Architecture Description

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September 29, 2022

Medical Device Translations: 3 Steps For Translating Software as a Medical Device

Every now and then, these questions come up:

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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.