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.
Unlimited user seats
We won't delete your data if you downgrade.
Unlimited Documents & Records
Store unlimited rich-text QMS documents and records.
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.
Advanced AI Features
Generate your QMS with our AI which pre-fills your documents for you.
IEC 62304 Requirements Management
Manage your software requirements and tests compliant with IEC 62304.
ISO 14971 Risk Management
Perform an ISO 14971 - compliant risk analysis for your medical device.
IEC 62366 Usability Engineering
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.
Customer & Audit Support
Reach out to customer support if you need help with technical problems, especially if you're in an audit.
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
49€ / month
+ VAT, billed monthly
All features of our most expensive tier (right side), at a much lower price. Only availble if your company has no funding, no revenue and 3 people or less. Includes AI features.
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.
Advanced AI Features
Generate your QMS with our AI which pre-fills your documents for you.
IEC 62304 Requirements Management
Manage your software requirements and tests compliant with IEC 62304.
ISO 14971 Risk Management
Perform an ISO 14971 - compliant risk analysis for your medical device.
IEC 62366 Usability Engineering
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.
Customer & Audit Support
Reach out to customer support if you need help with technical problems, especially if you're in an audit.
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
Everything you need for your medical device certification - set up your QMS with AI and document your medical devices in compliance with EU and FDA requirements.
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.
Advanced AI Features
Generate your QMS with our AI which pre-fills your documents for you.
IEC 62304 Requirements Management
Manage your software requirements and tests compliant with IEC 62304.
ISO 14971 Risk Management
Perform an ISO 14971 - compliant risk analysis for your medical device.
IEC 62366 Usability Engineering
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.
Customer & Audit Support
Reach out to customer support if you need help with technical problems, especially if you're in an audit.
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.
Chat with us now →