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.
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 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 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
ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes
Template: SOP Machine Learning Model Development (AI)
Template: Instructions On Data Annotation (Machine Learning / AI)
Don't worry - you're not alone.
Take a look at how you can get your compliance done efficiently.