OpenRegulatory (Formwork)
Weinheim-based eQMS and technical documentation tool for small medical device teams, priced from free to 499 euros a month
Quick Overview
| Company | OpenReg GmbH (OpenRegulatory) |
|---|---|
| Category | Quality Management Software (QMS) |
| Headquarters | Weinheim, Germany |
| Founded | Not stated |
| EU Presence | Yes - Germany (EU) |
| Data Location | France and Germany (as stated by the vendor) |
| Open Source | No |
| GDPR Compliant | Yes |
| Self-Hosting | No |
| Main Features | Document control, e-signatures (21 CFR Part 11), training, CAPA, technical documentation, risk management, usability tracking, AI-generated QMS drafts |
| Pricing | Free; Starter 99 euros per month; QMS + Techdoc 499 euros per month (plus VAT) |
| Best For | Founder-led medical device companies that need a QMS and technical file without a quality department |
| Replaces | MasterControl, spreadsheets and Jira-based QMS setups |
Detailed Review
The imprint names OpenReg GmbH, Kapellenstr. 6 in Weinheim, registered at the Amtsgericht Mannheim under HRB 757780, with Dr. Oliver Eidel as managing director.
The company grew out of free open templates for medical device regulation, and Formwork is the paid tool built on that expertise.
Prices you can read
Community Edition is free with 5 user seats. Formwork Starter costs 99 euros a month or 1,089 euros a year, and Formwork QMS + Techdoc costs 499 euros a month or 5,489 euros a year with unlimited seats, all plus VAT.
The vendor describes this as far cheaper than other eQMS providers, which is a claim, not a measured fact.
QMS and technical file together
Requirements, risks and tests are traced in one tree for software and hardware, and the ISO 13485, IEC 62304, ISO 14971 and IEC 62366 templates come preloaded. An AI step drafts SOPs and requirements from a product description for you to review.
No US hyperscalers
The FAQ states data sits in France and Germany on French and German hosting providers, and that Amazon, Google and Microsoft are not used because of GDPR concerns. There is no self-hosted edition.
Limitations to Consider
Formwork is built for medical devices only, so a pharma plant needing batch records or GMP deviation handling is outside its scope. Self-hosting is not offered, and the free tier limits QMS document management. Organisations with many sites and complex approval hierarchies may outgrow a tool aimed at lean founder teams; Ideagen is a larger-organisation option.
Who Should Use OpenRegulatory (Formwork)
Seed to Series A medical device and SaMD companies in Europe that want an audited QMS and technical documentation at a flat monthly price.
Pros and Cons
Pros
- Prices published for all tiers, starting at zero
- Data in France and Germany, no US cloud providers
- Traceability from requirements to risks to tests
- German GmbH with Handelsregister entry
- Templates for ISO 13485 and IEC 62304
Cons
- Medical devices only
- No self-hosting
- Limited document management on the free tier
- Not aimed at multi-site enterprises
Alternatives to OpenRegulatory (Formwork)
Other European quality management software (qms) worth comparing before you decide:
Qualio
Ireland · Cloud eQMS for medtech and biotech with AI gap analysis
SimplerQMS
Denmark · Pre-validated eQMS from Copenhagen with a listed starter price
Scilife
Belgium · Brussels eQMS for pharma and medical devices with module tiers
Cognidox
United Kingdom · Cambridge eQMS built on document control for device developers
See all European quality management software (qms) or compare them directly against MasterControl on our alternatives page.
Frequently Asked Questions
There is a free Community Edition, Formwork Starter at 99 euros a month and Formwork QMS + Techdoc at 499 euros a month, all plus VAT, with annual prices of 1,089 and 5,489 euros.
The FAQ says France and Germany, on French and German hosting providers, with no Amazon, Google or Microsoft cloud.
No. The vendor states it only offers Formwork as a cloud-hosted tool.