Formwork Pricing

Formwork is the #1 choice for lean, founder-led companies going for EU MDR or FDA medical device certification because of its advanced features and simple pricing.
Get started today with the free Community Edition and upgrade when you're ready.
Zero lock-in - cancel monthly and export your data any time.
Community Edition
Free
Free forever!
Free for everyone and perfect for you to get started. Better than Google Drive, Jira and Sharepoint. Access to all features, with some usage limitations.
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 your documents with FDA 21 CFR Part 11 compliant e-signatures.
IEC 62304 Requirements Management
(5 items)
Manage your 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 your user needs and usability tests in compliance with the IEC 62366.
Batch Export Your Data & Generate Audit Spreadsheets
Export all your data with one click and generate spreadsheets your auditors will love.
Automatically Train Your Employees
Show your auditors that you fulfill your 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.
No Customer & Audit Support
(do it yourself)
Reach out to customer support if you need help with technical problems, especially if you're in an audit.
Release Your Product
Finalize your documentation for your audit by releasing your product documentation
ISO 13485 Validation Report
Receive an ISO 13485 - compliant validation report of Formwork to show your auditors that it's a compliant QMS software.
Formwork Starter
99€ / month
+ VAT, billed monthly - no commitment
Almost all features of the 499€ tier. Perfect for preparing everything for your certification. No usage limitations except product releases. Includes AI features.
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 your documents with FDA 21 CFR Part 11 compliant e-signatures.
IEC 62304 Requirements Management
(unlimited)
Manage your 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 your user needs and usability tests in compliance with the IEC 62366.
Batch Export Your Data & Generate Audit Spreadsheets
Export all your data with one click and generate spreadsheets your auditors will love.
Automatically Train Your Employees
Show your auditors that you fulfill your 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 to customer support if you need help with technical problems, especially if you're in an audit.
Release Your Product
Finalize your documentation for your audit by releasing your product documentation
ISO 13485 Validation Report
Receive an ISO 13485 - compliant validation report of Formwork to show your auditors that it's a compliant QMS software.
Formwork QMS + Techdoc
499€ / month
+ VAT, billed monthly - no commitment
Everything you need for your medical device certification - set up your QMS with AI and document your EU MDR and/or FDA medical devices. No limitations.
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 your documents with FDA 21 CFR Part 11 compliant e-signatures.
IEC 62304 Requirements Management
(unlimited)
Manage your 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 your user needs and usability tests in compliance with the IEC 62366.
Batch Export Your Data & Generate Audit Spreadsheets
Export all your data with one click and generate spreadsheets your auditors will love.
Automatically Train Your Employees
Show your auditors that you fulfill your 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 to customer support if you need help with technical problems, especially if you're in an audit.
Release Your Product
Finalize your documentation for your audit by releasing your product documentation
ISO 13485 Validation Report
Receive an ISO 13485 - compliant validation report of Formwork to show your auditors that it's a compliant QMS software.
Any questions about pricing?
Send us a message any time, we're happy to help.
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