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Pricing & features.

Formwork is the #1 choice for lean, founder-led companies going for EU MDR, FDA or Health Canada compliance — advanced features, simple pricing.

Get started today with the free Community Edition and upgrade when you’re ready.

Flat prices, extremely affordable. 6x–10x cheaper than other eQMS providers.

Community Edition

Free forever

Free forever!

Free and perfect for getting started. Better than Google Drive, Jira and Sharepoint. Access to all features, with usage limitations.

Sign up free
5 user seats
Perfect for up to five dudes or dudesses working in a garage.
10 Documents & 10 Records
Store rich-text QMS documents and records, with usage limitations.
Upgrade any time
Upgrade to a higher subscription when you're ready.
ISO 13485 Compliance
Set up a fully ISO 13485 - compliant QMS.
FDA 21 CFR Part 11 Compliance
Sign documents with FDA 21 CFR Part 11 compliant e-signatures.
IEC 62304 Requirements Management (5 items)
Manage software requirements and tests compliant with IEC 62304.
ISO 14971 Risk Management (5 items)
Perform an ISO 14971-compliant risk analysis for your medical device.
IEC 62366 Usability Engineering (5 items)
Manage user needs and usability tests in compliance with IEC 62366.
Batch export & audit spreadsheets
Export all your data with one click and generate spreadsheets your auditors will love.
Automatically train your employees
Fulfill ISO 13485 training requirements with automatic user training quizzes.
Advanced AI features
Generate your QMS with our AI which pre-fills your documents for you.
Customer & audit support
You're on your own for technical problems or audit questions with this plan.
Release your product
Finalize documentation for your audit by releasing product documentation.
ISO 13485 validation report
Receive an ISO 13485 - compliant validation report of Formwork.
Custom agreements (NDA, DPA, QAA)
We sign custom agreements your company may need for compliance.
Free migration service
We help you migrate your QMS from another eQMS software.

Formwork Starter

99€ /month

+ VAT, billed monthly or yearly

Almost all features of the 499€ tier. Perfect for preparing for certification. No usage limits except product releases. Includes AI.

Sign up free
5 user seats
Perfect for up to five dudes or dudesses working in a garage.
Unlimited Documents & Records
Store unlimited rich-text QMS documents and records.
Up-/downgrade any time
Up- or downgrade monthly, no data gets lost.
ISO 13485 Compliance
Set up a fully ISO 13485-compliant QMS.
FDA 21 CFR Part 11 Compliance
Sign documents with FDA 21 CFR Part 11 compliant e-signatures.
IEC 62304 Requirements Management (unlimited)
Manage software requirements and tests compliant with IEC 62304.
ISO 14971 Risk Management (unlimited)
Perform an ISO 14971-compliant risk analysis for your medical device.
IEC 62366 Usability Engineering (unlimited)
Manage user needs and usability tests in compliance with IEC 62366.
Batch export & audit spreadsheets
Export all your data with one click and generate spreadsheets your auditors will love.
Automatically train your employees
Fulfill ISO 13485 training requirements with automatic user training quizzes.
Advanced AI features
Generate your QMS with our AI which pre-fills your documents for you.
Customer & audit support (limited)
Reach out for technical problems, especially during an audit.
Release your product
Finalize documentation for your audit by releasing product documentation.
ISO 13485 validation report
Receive an ISO 13485 - compliant validation report of Formwork.
Custom agreements (NDA, DPA, QAA)
We sign custom agreements your company may need for compliance.
Free migration service
We help you migrate your QMS from another eQMS software.
Most popular

Formwork QMS + Techdoc

499€ /month

+ VAT, billed monthly or yearly

Everything for medical device certification. Set up your QMS with AI and document your EU MDR and/or FDA devices. No limits.

Sign up free
Unlimited user seats
We won't delete your data if you downgrade.
Unlimited Documents & Records
Store unlimited rich-text QMS documents and records.
Up-/downgrade any time
Up- or downgrade monthly, no data gets lost.
ISO 13485 Compliance
Set up a fully ISO 13485-compliant QMS.
FDA 21 CFR Part 11 Compliance
Sign documents with FDA 21 CFR Part 11 compliant e-signatures.
IEC 62304 Requirements Management (unlimited)
Manage software requirements and tests compliant with IEC 62304.
ISO 14971 Risk Management (unlimited)
Perform an ISO 14971-compliant risk analysis for your medical device.
IEC 62366 Usability Engineering (unlimited)
Manage user needs and usability tests in compliance with IEC 62366.
Batch export & audit spreadsheets
Export all your data with one click and generate spreadsheets your auditors will love.
Automatically train your employees
Fulfill ISO 13485 training requirements with automatic user training quizzes.
Advanced AI features
Generate your QMS with our AI which pre-fills your documents for you.
Customer & audit support (unlimited)
Reach out for technical problems, especially during an audit.
Release your product
Finalize documentation for your audit by releasing product documentation.
ISO 13485 validation report
Receive an ISO 13485-compliant validation report to show your auditors.
Custom agreements (NDA, DPA, QAA)
We sign custom agreements your company may need for compliance.
Free migration service
We help you migrate your QMS from another eQMS software.

Compare pricing with the rest of the market.

Tired of hitting those “Talk to Sales” buttons to find out about eQMS pricing? We’ve done it for you. Spoiler: Formwork is 6x–40x cheaper.

Free migration

Switching from another eQMS, e.g. Greenlight Guru or Matrix? We’ll migrate your data for free.

Learn more →
Vendor First year (min) Per extra user Commitment
Formwork (QMS + Techdoc) You are here
€0–5,988 Free! None · monthly
Greenlight Guru €24,000+ ~€2,000 / yr 2–3 years
Qualio €24,000+ ~€1,200 / yr 2–3 years
Matrix Requirements €7,320 €780 / yr 1 year

First-year cost computed at the vendor’s minimum monthly rate, before discounts. Sources: published rates and our interviews with medical device startups — reach out to vendors directly for a binding quote.

Ready to streamline your medical device compliance?

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app.openregulatory.com / cardio-monitor / audit
Cardio Monitor · v2.4

Audit readiness

100%
32 SOPs signed QMS
47 requirements traced Techdoc
18 risks mitigated Risk
21 CFR Part 11 ready Compliance
→ Ready for ISO 13485 audit