Compliance, without the complications.
Bring your software to market as a medical device - with our Wizard, articles, free templates and eQMS software.
Compliance, without the complications.
Bring your software to market as a medical device - with our Wizard, articles, free templates and eQMS software.
111
Articles
30
Questions answered
83
Free Templates
100+
Consulting Customers
1100+
eQMS Users
800+
Community Members
We are four dudes who are passionate about making compliance simple and helping Healthcare startups enter the market.
Dr. Oliver Eidel
Medical Doctor, Software Engineer
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 Piechottka
QMS Compliance and Data Privacy
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 Hornof
Technical Documentation
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.
Ale Solano
Software Developer
Ale studied robotics engineering and AI. He learned about the regulatory struggles of Healthcare startups when he founded his own digital therapeutics company. Now, at OpenRegulatory, he wants to bring hackers into healthcare by enabling them to launch faster.
Free QMS Software: Google Drive, SharePoint, GitHub, GitLab And Others
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ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes
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Template: SOP Machine Learning Model Development (AI)
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Template: Instructions On Data Annotation (Machine Learning / AI)
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Don't worry - you're not alone.
Take a look at how you can get your compliance done efficiently.