Formwork Pricing

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

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

And yes, those are flat prices per month - up to 20x cheaper than our competitors.

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) You're on your own for technical problems or audit questions with this plan.
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.
Sign custom agreements (NDA, DPA, QAA) We sign custom agreements your company may need for compliance.

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.
Sign custom agreements (NDA, DPA, QAA) We sign custom agreements your company may need for compliance.

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.
Sign custom agreements (NDA, DPA, QAA) We sign custom agreements your company may need for compliance.

Compare Pricing

Tired of hitting those "talk to sales" buttons to learn about eQMS pricing?

Formwork is the only eQMS software with affordable, transparent pricing.

Here's a handy comparison table. Spoiler: Formwork is 6x - 40x cheaper.

	Formwork	Greenlight Guru	Qualio	Matrix Requirements
Monthly price	free / 99€ / 499€	2-4k€	2-4k€	610€
Minimum commitment	1 month	2-3 years	2-3 years	1 year
Notes	Flat price, no commitment (cancel monthly)	Price goes up with user seats	Price goes up with user seats	Price goes up with user seats
Affordability vs. Formwork (99€)	Most affordable	20x - 40x more expensive!	20x - 40x more expensive!	6x more expensive!

Prices above are minimum prices, i.e. the minimum price a company would typically have to pay to purchase an eQMS. Source: Our interviews with medical device startups. Actual prices may differ - reach out to them directly to receive a binding quote (yes, that means you have to hit the dreaded "talk to sales" button).

Ready To Streamline Your Compliance?

Join thousands of fast-moving companies solving their medical device compliance with Formwork.

Start your free trial now, chat with us, or schedule a demo.

Got questions? Reach out any time, we're happy to help!