Formwork is an electronic quality management system for medical device teams, with QMS and technical documentation plans.
Formwork Community Edition includes templates for ISO 13485, FDA 21 CFR Part 11, IEC 62304 and ISO 14971.
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Formwork Review 2026: Pricing, Plans and Medical Device eQMS
Formwork is an electronic quality management system for medical device teams, with QMS and technical documentation plans.
Verified
Facts at a glance
- Starting price
- Community Edition: Free forever, with 5 user seats. · as of October 2026
- Free plan
- Formwork Community Edition is free forever.
- Free trial
- Not documented
- Official website
- https://openregulatory.com/
- Category
- Quality Management Software
- Last verified
- 2026-10-21
Key capabilities
Best Quality Management Software 2026
| Controlled document revision history | Not documented |
|---|---|
| Controlled document approval workflow | Not documented |
| CAPA workflow | Not documented |
| Audit management | Not documented |
Best Medical Device QMS Software 2026
| Medical-device standards focus | ISO 13485; FDA 21 CFR Part 11; IEC 62304; ISO 14971 |
|---|---|
| 21 CFR Part 11 support statement | FDA 21 CFR Part 11 compliant e-signatures |
| Electronic signatures | Not documented |
Best Quality Management Software for Small Businesses 2026
| Vendor-stated target company size | Lean, founder-led medical device companies |
|---|---|
| Published QMS price | Formwork publishes Community Edition, Starter and QMS + Techdoc prices. |
| Free plan | Formwork Community Edition is free forever. |
| Free trial | Not documented |
Appears in these comparisons
Consider instead
- Greenlight Guru eQMS — Shares 3 shortlists; ranked above Formwork on Best Quality Management Software 2026
- Ketryx eQMS — Shares 3 shortlists; ranked above Formwork on Best Quality Management Software 2026
- isoTracker Quality Management Software — Shares 3 shortlists; ranked above Formwork on Best Quality Management Software 2026
Change log
- 21 October 2026 — Checked 21 facts including Starting price, Free plan, Free trial, Price published