OpenRegulatory
Company profile
Company Overview
OpenRegulatory is an AI-powered electronic Quality Management System (eQMS) provider that simplifies medical device compliance for lean teams. Their platform supports compliance with EU MDR and FDA standards, enabling companies to finish documentation efficiently while continuously shipping products.
The company offers open templates, transparent pricing, and a focus on making compliance accessible, transparent, and free through various document templates covering ISO 13485, IEC 62304, ISO 14971, and IEC 62366. Established for over 5 years, OpenRegulatory has passed EU MDR and FDA audits and serves thousands of companies.
Mission and Culture
OpenRegulatory is driven by the belief that healthcare needs fixing due to slow innovation and misaligned incentives. The company is 100% bootstrapped, profitable, and dedicated to building valuable software tailored for healthcare startups and small problems that need solving.
The work culture emphasizes trust, work-life balance with a four-day workweek, and transparency among team members, including sharing profits as bonuses. They maintain minimal meetings and asynchronous communication, promoting autonomy and accountability in the team.
Leadership and Team
Founder & CEO: Dr. Oliver Eidel (Germany)
Key team members include software developers and consultants based in Spain, India, and Germany. The company also benefits from expert advisors with backgrounds in neuroradiology and product development in healthcare technology.
Jobs
OpenRegulatory posts its job openings on the Digital Health Jobs platform, focusing on roles related to healthcare startups and regulatory compliance.
