OpenRegulatory

Company Overview

OpenRegulatory is a company focused on simplifying medical device compliance through their AI-powered eQMS platform, especially for EU MDR and FDA regulations. They provide open templates, transparent pricing, and a comprehensive compliance playbook. The company aims to make regulatory compliance accessible, transparent, and efficient for lean teams, enabling them to ship products regularly while maintaining compliance.

OpenRegulatory has been operational for over 5 years, successfully passing EU MDR and FDA audits, serving thousands of companies. Their core product, Formwork, replaces traditional document storage and management tools with an AI-powered electronic Quality Management System designed to speed up the compliance process.

Mission and Vision

The company believes healthcare needs innovation and fixing due to slow progress, misaligned incentives, and a lack of transparency in the compliance industry. OpenRegulatory is committed to fixing these issues by providing transparent, accessible, and freely available solutions, including free document templates covering ISO 13485, IEC 62304, ISO 14971, and IEC 62366 standards.