Compliance, without the complications.
Bring your software to market as a medical device - with our Wizard, articles, free templates and eQMS software.
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Questions answered
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Free Templates
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Consulting Customers
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eQMS Users
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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.
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.
Saurabh Sikchi
Software Developer
Saurabh studied Computer Science and Engineering. He learned technology to build and scale startups, and has a background contributing to them. At OpenRegulatory he wants to help healthcare companies by enabling them with tech, tools and services that are far ahead of the market.
Template: Internal Audit Report
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Template: Literature Evaluation Table (MDR Clinical Evaluation)
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How MDD Devices Die: Two Case Studies From The Real World
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What Is a Clinical Development Plan?
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Don't worry - you're not alone.
Take a look at how you can get your compliance done efficiently.