Formwork eQMS

Formwork is a cloud-based, GDPR-compliant electronic Quality Management System (eQMS) developed by OpenRegulatory, aimed at medical device startups and lean, founder-led companies. It supports compliance with EU MDR, IVDR, and FDA regulations for both software and hardware medical devices. The platform covers document management, technical documentation, risk management, usability tracking, training, and CAPA management in a single system.

Formwork has been on the market for approximately six years and has been used by customers who have passed EU MDR, FDA, and Health Canada audits. It is offered at flat monthly prices — free, 99€, or 499€ — with no long-term commitment required. Data is hosted in France and Germany, with no reliance on US-based cloud providers, in response to GDPR considerations.

Core Capabilities

• QMS document management for ISO 13485, including document creation using templates and a rich-text editor, review workflows, versioning, and archiving
• Technical documentation management for both software (IEC 62304) and hardware medical devices, covering requirements management and test case management
• Risk management with visualizations, aligned with ISO 14971
• Usability data tracking per IEC 62366
• Training and CAPA management
• FDA 21 CFR Part 11-compliant electronic signatures
• AI-assisted QMS generation that pre-fills documents based on user inputs, enabling a first draft in a short time
• Instant feedback on the completeness of technical documentation
• Product release functionality to finalize documentation for audits
• ISO 13485 validation report provided to paying customers at no additional charge

Supported Standards and Regulatory Frameworks

• EU MDR (Medical Device Regulation) — device classes I, IIa, and IIb
• EU IVDR (In Vitro Diagnostic Regulation)
• FDA compliance, including 21 CFR Part 11
• Health Canada compliance
• ISO 13485 quality management
• IEC 62304 software lifecycle
• ISO 14971 risk management
• IEC 62366 usability engineering

Pricing Tiers

• Community Edition (Free): Up to 5 user seats, access to all features with usage limitations (e.g., up to 10 documents), QMS and technical documentation management, AI features, FDA 21 CFR Part 11 e-signatures, and customer and audit support. Suitable for initial setup and early-stage documentation.
• Formwork Starter (99€/month): Up to 5 user seats, unlimited QMS and technical documentation management, AI features, FDA 21 CFR Part 11 e-signatures, product release capability, ISO 13485 validation report, and limited audit support. Suitable for completing documentation ahead of a first audit.
• Formwork QMS + Techdoc (499€/month): Unlimited user seats, all features without usage limitations, full audit support, product release, ISO 13485 validation report, and AI features. Intended for companies preparing for or undergoing certification audits.

Data Management and Export

• All data can be exported at any time in PDF, Markdown, or Excel formats
• Data is stored redundantly across mirrored SQL servers and object storage
• Hosting is provided by French and German providers; no US-based cloud infrastructure is used
• Formwork is available only as a cloud-hosted tool; self-hosted deployment is not supported

Collaboration and Integrations

• OpenRegulatory is collaborating with BerlinCert, a Notified Body focused on Software as a Medical Device (SaMD), on data formats for audit submissions
• Formwork does not integrate with Jira, Confluence, or other development tools; OpenRegulatory states this decision is based on their assessment that no practical use case for such integrations was found across 150+ companies they have worked with

OpenRegulatory states that the company has been profitable since its founding and remains fully founder-owned, with no external venture capital investors. Yearly billing is available with one month provided at no charge. A free migration service is also offered for companies moving from other systems.