OpenRegulatory

OpenRegulatory develops medical device compliance software and free regulatory resources, primarily serving lean medical device and software-as-a-medical-device (SaMD) teams. The company has been operating for approximately six years and states that its customers have passed EU MDR, FDA, and Health Canada audits. Its stated mission is to make medical device compliance transparent, accessible, and free.

The company offers a combination of a paid eQMS software product called Formwork, freely available document templates, a regulatory learning library, a community forum, and paid consulting services.

Formwork — eQMS Software

• Formwork is an AI-powered electronic Quality Management System (eQMS) designed to replace general-purpose tools such as Google Drive, Jira, and SharePoint for medical device documentation workflows.
• Built to support ISO 13485 and EU MDR compliance out of the box.
• Includes real-time completeness checks and PDF export functionality.
• Provides audit-proof electronic signatures compliant with FDA 21 CFR Part 11.
• Intended to allow teams to complete EU MDR or FDA documentation while continuing to ship product on a regular cadence.
• Available on both free and paid tiers.

Free Document Templates

• OpenRegulatory publishes a library of medical device document templates at no cost, with no conditions attached.
• Templates cover the following standards: ISO 13485, IEC 62304, ISO 14971, and IEC 62366.
• Available for download in Word, PDF, Markdown, and HTML formats.
• Hosted publicly on GitHub.
• Example templates include: SOP Human Resources Administration, Risk Management Plan, Quality Manual/Policy/Objectives, and a Cybersecurity for Medical Devices Technical Documentation questionnaire.

Learning Resources and Community

• OpenRegulatory provides a free library of articles, Q&A content, and videos covering regulatory compliance topics for medical devices.
• A free community forum allows users to ask questions, share audit experiences, and receive answers from peers and OpenRegulatory staff.
• Example community content includes discussions on whether internally used diagnostic software qualifies as a medical device under MDR, and video guides on generating QMS and technical documentation using AI tools.

Consulting Services

• OpenRegulatory offers paid, hands-on consulting services providing customised regulatory guidance.
• Consulting is described as tailored to a specific product and timeline, with the goal of achieving compliance efficiently.

OpenRegulatory is a small team based across Germany, Spain, and India, founded and led by Dr. Oliver Eidel. The company positions itself as an alternative to what it describes as a non-transparent compliance industry, and publishes its pricing openly alongside its templates and educational content.