Compliance, without the complications.
Bring your medical device to market - with our Wizard, articles, free templates and eQMS software.
Compliance, without the complications.
Bring your medical device to market - with our Wizard, articles, free templates and eQMS software.
“As a medical startup, we initially had no knowledge of MDR and the associated regulations. However, the videos, tutorials, and templates from OpenFramework Regulatory were incredibly helpful. They equipped us with the necessary knowledge to implement our processes effectively and successfully achieve the certification (Class IIb). I highly recommend their resources to any startup. Their templates and tutorials are not only informative but also adaptable to specific needs. An excellent resource indeed.”
123
Articles
35
Questions answered
85
Free Templates
100+
Consulting Customers
1.700+
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.
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.
Launching Formwork Starter: 49€ For QMS Software And Requirements Management
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Unlocking Market Access: Navigating Reimbursement Challenges for Medical Device Startups in Europe
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MDR Post-Market Surveillance: The Ultimate Guide
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What Is Clinical Evidence (MDR)?
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Don't worry - you're not alone.
Take a look at how you can get your compliance done efficiently.