ReviewsFormwork

Formwork review

A flat-priced, self-serve eQMS for medical device startups, with built-in templates and structured technical documentation for software. Document control, design records, CAPA and supplier control are documented; complaints, internal audits and change control much less so.

Price
$7k/yr499 € a month flat for unlimited users; 99 € for up to 5
Free trial
Free tierSelf-serve sign-up, no sales call
EU hosting
France (backups in Germany)DPA generated in the app; no public subprocessor list
Last checked
Oct 2026
Placeholder data: some scores, prices and features on this page have not been verified yet.

What we like

  • Published flat prices: free for up to 5 users with usage caps, 99 € a month for 5 users, 499 € a month for unlimited users, with no setup or validation fees.
  • Documented CAPA, supplier and training workflows, plus non-conformity tracking, including criticality-based supplier re-evaluation and training quizzes.
  • Structured technical documentation: requirements, tests, test runs and ISO 14971 risk items are linked, versioned per release and exported as audit spreadsheets.
  • IEC 62304 built in: safety class per product, requirement categories and detailed design for class C.
  • Hosted in France with backups in Germany, and self-service export of documents and records as PDF or Markdown.

What to watch

  • We found no complaint handling, internal audit planning, vigilance reporting, UDI or production record features, and change requests are barely documented.
  • No usable user ratings: 2 reviews on G2, none on Capterra, and no independent community discussion.
  • The terms of service describe yearly auto-renewal with 30 days' written notice, which contradicts the 'cancel any time' marketing.
  • No Jira or Git integration, no public API, no SAML SSO, and no ISO 27001 or SOC 2 statement found.
  • Starter can't release product documentation, so in practice any team heading for an audit needs the 499 € tier.

About the price: QMS + Techdoc at 499 € a month plus VAT (about $6,800 a year at the 30 Sep 2026 ECB rate; $6,230 billed yearly), unlimited users. Needed for 6+ users and to release product documentation for an audit. Starter is 99 € a month for up to 5 users; a limited Community Edition is free. Prices checked on the vendor's pricing page on 1 Oct 2026.

What is Formwork?

Formwork is an eQMS made by OpenRegulatory (OpenReg GmbH), a German company registered in 2020 (see “Company and ownership” below).1 The founder says he started building it in 2020, after OpenRegulatory first became known for free EU MDR document templates.2 The company also sells regulatory consulting and video courses.34

The vendor pitches Formwork at “lean, founder-led” companies working towards EU MDR, IVDR or FDA compliance, for both software and hardware devices.3 It says most users target EU MDR class I to IIb, with far fewer going for FDA.3 It claims “thousands of companies” use it; we couldn’t verify that.3

The product has two halves: a QMS section for documents, records, CAPAs, suppliers and trainings, and a “Techdoc” section for each product’s requirements, tests, risk management and usability files.56

Who Formwork is for

Formwork fits device startups that:

  • want a QMS for a few hundred euros a month, with prices published;7
  • build software as a medical device and need IEC 62304 and ISO 14971 records linked to each other;86
  • would rather start from templates and sign up without a sales call.59

Look elsewhere if you:

  • Make physical devices at volume. Suppliers and non-conformities are covered,1011 but we found no disposition step, complaint handling or production record features.
  • Need tight links to Jira or Git. The vendor says it has no development-tool integration, by design.3
  • Are a larger company. We found no SAML single sign-on, public API or enterprise references.

Formwork pricing

Formwork publishes three tiers (checked 1 October 2026; plan details from the February 2026 version of the page):127

  • Community Edition: free, 5 users, up to 10 documents and 10 records, no support.
  • Starter: 99 € a month plus VAT, 5 users, no usage limits, but you can’t release product documentation and there’s no validation report or free migration.
  • QMS + Techdoc: 499 € a month plus VAT, unlimited users, all features, validation report, custom agreements (NDA, DPA, QAA) and free migration.

Paying yearly gives one month free.12 A German tool directory listed the same prices in June 2026.13

A 10-person team needs QMS + Techdoc, because the other tiers stop at 5 users.7 The vendor also says releasing (versioning) product documentation, which you need for an audit, is only possible on that tier.14 That is 5,988 € a year billed monthly, or 5,489 € billed yearly, about $6,800 or $6,230.715 We found no setup, validation or onboarding fees. Until March 2025 the same tier was listed at 799 € a month, with 499 € as a startup discount.16

Features

Document control and records

Documents are versioned and released only after review, are locked once released, and have an activity log.17 Reviews go to roles rather than named people.18 Records can be released by their author, and released records can be amended with a stated reason.19 The built-in editor stores content as Markdown, and Word files can be uploaded as file-based documents.17

E-signatures

Users re-enter their credentials when they sign or release, and the vendor claims 21 CFR Part 11 compliant e-signatures.177

Design controls, risk and software

Each product records whether it is software, hardware or both, and its IEC 62304 safety class; class C adds detailed design.6 Requirements (called design inputs for hardware) link to stakeholder requirements, failure modes, risk controls and tests.8 Links between tests and requirements are bi-directional.20 Risk management covers hazards, hazardous situations, harms, failure modes, a risk matrix and risk controls.6 Product documentation is versioned per release, and an audit export generates spreadsheets such as the software requirements list.621

Non-conformities and CAPA

Non-conformities record anything that missed a requirement, from an audit finding to a failed batch, and a major one has to be linked to a CAPA.11 We found no documented disposition step (rework, scrap or concession) for nonconforming product. CAPAs cover root cause, actions, verification and a check that they worked, and can also start from field incidents, audits or management reviews.11 CAPA isn’t available on the free plan.11

Suppliers

Each supplier gets a category, a status and a criticality of A, B or C, which sets re-evaluation every one, two or three years.10 Formwork works out when the next evaluation is due and exports a list of qualified suppliers.10

Training and change control

Trainings are set per role, usually reading approved documents, and Formwork records completion and effectiveness through a quiz or a named person’s confirmation.22 Training management isn’t available on the free plan.22 Product change requests are reviewed by role, but we found no description of the change workflow.186

Complaints and audits

We found no documented complaint handling, internal audit planning, UDI or vigilance reporting features. Internal audits appear only as a source of CAPAs.11

Templates and AI

OpenRegulatory’s templates are built into the QMS section.5 AI drafting fills in documents; your intended use and related items go to OpenAI only when you click generate.323

What users say

Formwork has 2 reviews on G2 (5.0/5, September 2026), below the 10 we need for a rating.24 Its Capterra listing has no reviews.25 We found no independent first-hand discussion: a 2023 Reddit thread asked about it but had no user experiences, and the one Reddit question titled “Formwork QMS software experiences?” got no replies.2627 The testimonials on the vendor’s site, including customers who say they passed MDR and ISO 13485 audits, are chosen by the vendor.28

Security, hosting and validation

Formwork runs on French hosting providers, with daily backups in Germany, and avoids US cloud providers.329 There is no self-hosted option.3 The privacy policy names PostHog and Crisp as service providers, but there is no public subprocessor list or public DPA.2330

Customers can generate a validation report with screenshots of each tested requirement, a data processing agreement and a quality assurance agreement in the app’s settings.30 In February 2026 the validation report was limited to QMS + Techdoc.3 We found no ISO 27001 or SOC 2 statement. Sign-in with Google is supported; we found no SAML single sign-on.9

Buying and contract terms

You can sign up for the free tier yourself, and the vendor offers a self-guided demo video instead of a sales call.931 Free trials of paid tiers are available on request.32

The marketing says there’s no minimum commitment beyond a month and that you cancel with a button.1214 The terms of service say the agreement renews for one-year periods unless cancelled in writing 30 days before the end of the term, and that renewal fees may rise once a year.33 We score the term as annual, because the terms are binding. Ask for the term in writing before you buy.

The terms put no cap on renewal increases and let the vendor add new charges at the end of any term, with 30 days’ notice.33 List prices have moved both ways. In March 2025 the QMS + Techdoc list price fell from 799 € to 499 €,16 while the Starter tier went from 49 € a month, then only for unfunded startups of up to three people, to 99 € a month for everyone, capped at 5 users.343536 We found no statement on whether existing customers kept their old price. Because the top tier has unlimited users at a flat price, growing from 10 to 25 people doesn’t change the bill.12

The terms don’t say what happens to your data if OpenReg GmbH becomes insolvent, stops the service or is sold. They allow one CSV export on request before the contract ends, and the vendor may transfer the agreement to another party.33 Use the self-service export regularly rather than relying on the terms.

Documents and records can be exported at any time as PDF or Markdown, and technical documentation as spreadsheets.373 The terms also promise a CSV export on request.33 We found no public API documentation; the manual lists pages on connecting AI tools through MCP with machine tokens.38

The vendor says no setup is needed, and its free migration service on QMS + Techdoc usually takes one to two weeks.3239

Company and ownership

OpenReg GmbH was registered on 15 December 2020 at the Berlin-Charlottenburg local court (HRB 224186 B), with share capital of €25,000.1 On 19 March 2026 the company moved its seat to Weinheim and is now registered at the Mannheim local court as HRB 757780. On the same date the company’s managing director changed for the first time since 2020.1 New articles of association and a new shareholder list were filed in January and February 2026; we couldn’t read their contents.1

The company’s legal entity identifier record lists no parent company and says it is owned by individuals.40 The vendor said in February 2026 that the company is profitable and 100% owned by its founder.2 We found no funding rounds, no acquisitions and no published annual accounts.

Verdict

Shortlist Formwork if you’re an early-stage startup, especially one building software, that wants published flat pricing, built-in templates and linked requirements, risk and test records. Look elsewhere if you need complaint handling, internal audit or vigilance features, development-tool integrations or enterprise features. There are almost no independent user reviews yet, and the contract term in the terms of service doesn’t match the marketing.

  1. North Data: OpenReg GmbH. Mirror of German commercial register publications, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎

  2. Formwork Manual: Welcome, archived 10 Feb 2026. Vendor documentation, published 20 Jan 2026, checked 1 Oct 2026. ↩︎ ↩︎

  3. Formwork product page and FAQ, archived 19 Feb 2026. Vendor website (Wayback Machine), checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  4. Video courses in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎

  5. Managing your QMS in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎ ↩︎ ↩︎

  6. Documenting your medical device in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  7. Formwork pricing, archived 15 Feb 2026. Vendor website (Wayback Machine), checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  8. Software requirements and design inputs in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎ ↩︎

  9. Formwork sign-up page. Vendor website, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎

  10. Formwork Manual: Suppliers. Vendor documentation, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎

  11. Formwork Manual: Non-conformities and CAPAs. Vendor documentation, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  12. Formwork pricing. Vendor website, checked in a browser 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎

  13. KI-Syndikat: Formwork. Tool directory (editorial, no hands-on test), checked 13 Jun 2026 by the publisher, read 1 Oct 2026. ↩︎

  14. Formwork eQMS pricing, and when you should upgrade, archived 21 May 2025. Vendor documentation, updated 5 Mar 2025. ↩︎ ↩︎

  15. Frankfurter: ECB reference rate EUR/USD. Reference data, 1 EUR = 1.1355 USD on 30 Sep 2026. ↩︎

  16. How to purchase Formwork with the startup discount, archived 26 Mar 2025. Vendor documentation, updated 5 Mar 2025. ↩︎ ↩︎

  17. Creating QMS documents in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎ ↩︎ ↩︎

  18. Reviewer roles in Formwork, archived 21 May 2025. Vendor documentation, updated 1 Oct 2024. ↩︎ ↩︎

  19. Creating QMS records in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎

  20. Software and hardware tests in Formwork, archived 21 May 2025. Vendor documentation, updated 1 Oct 2024. ↩︎

  21. Formwork: generate technical documentation automatically (audit export), archived 21 May 2025. Vendor release article, updated 1 Oct 2024. ↩︎

  22. Formwork Manual: Trainings and roles. Vendor documentation, checked 1 Oct 2026. ↩︎ ↩︎

  23. Formwork privacy policy. Vendor legal page, checked 1 Oct 2026. ↩︎ ↩︎

  24. G2: Formwork eQMS reviews. Review site, checked 30 Sep 2026. ↩︎

  25. Capterra: Formwork. Review site, checked 1 Oct 2026. ↩︎

  26. r/MedicalDevices: What QMS software should you use?. Community forum, Sep 2023, read via the Arctic Shift archive 1 Oct 2026. ↩︎

  27. r/MedicalDevices: Formwork QMS software experiences?. Community forum, Jul 2024, read via the Arctic Shift archive 1 Oct 2026. ↩︎

  28. Formwork testimonials, archived 18 Feb 2026. Vendor website (Wayback Machine), checked 1 Oct 2026. ↩︎

  29. How we keep your Formwork data safe, archived 25 Apr 2025. Vendor article, updated 1 Oct 2024. ↩︎

  30. Formwork Manual: Compliance files. Vendor documentation, checked 1 Oct 2026. ↩︎ ↩︎

  31. Formwork: Schedule a demo, archived 17 Oct 2025. Vendor website (Wayback Machine), checked 1 Oct 2026. ↩︎

  32. OpenRegulatory: Formwork QMS software review, archived 17 Oct 2025. Vendor website, updated 8 May 2024. ↩︎ ↩︎

  33. Formwork terms of service. Vendor legal page, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎

  34. Formwork eQMS pricing, and when you should upgrade, archived 8 Sep 2024. Vendor documentation (Wayback Machine), checked 1 Oct 2026. ↩︎

  35. Formwork pricing, archived 25 Apr 2025. Vendor website (Wayback Machine), checked 1 Oct 2026. ↩︎

  36. Launching Formwork Starter, update note of Jul 2025, archived 15 Aug 2025. Vendor article (Wayback Machine), checked 1 Oct 2026. ↩︎

  37. No lock-in, ever: Formwork batch export, archived 25 Apr 2025. Vendor release article, updated 1 Oct 2024. ↩︎

  38. Formwork Manual (index). Vendor documentation, checked 1 Oct 2026. ↩︎

  39. Formwork: Free migration service, archived 29 Jan 2026. Vendor website (Wayback Machine), checked 1 Oct 2026. ↩︎

  40. GLEIF: LEI record 98450055C3DNCVBBE591, parent reporting exception. Global LEI registry, checked 1 Oct 2026. ↩︎

Visit the Formwork website (made by OpenRegulatory (OpenReg GmbH))

Notable features

Built-in document editorYesRich-text editor with tables and images, stored as Markdown
Edit in Word or Google DocsNot confirmed yetWord files can be uploaded but not edited in place; no documented Office or Google Docs editing
SOP templates includedYesOpenRegulatory's free QMS and technical documentation templates built in
Jira or Git integrationNoVendor says there's no Jira or development-tool integration, by design
IEC 62304 software featuresYesSafety class per product, requirement categories, detailed design for class C, tests and test runs
Validation package includedYesPre-filled validation report with screenshots of each tested requirement, generated in the app
Public APIPartly or add-onNo REST API docs found; the manual lists MCP access with machine tokens
Single sign-on (SSO)Partly or add-onGoogle sign-in; no SAML SSO found
Supplier portalNot confirmed yetSupplier list for your own evaluations; no supplier access found
Training with quizzesYesTraining effectiveness by quiz or a named person (paid plans)
FDA MDR or EU vigilance reportingNot confirmed yetNo FDA MDR or EU vigilance reporting feature found
AI featuresYesAI drafting of QMS and technical documents; data goes to OpenAI only when you click generate

ISO 13485 clause coverage

ClauseRequirementFormwork
4.2.4Control of documents
4.2.5Control of records
6.2Training and competence
7.3Design and development
7.3.9Change control
7.4Supplier qualification and control
7.5Production records (DMR/DHR)
UDIUDI management (EU MDR, FDA)
8.2.2Complaint handling
8.2.3Regulatory reporting (FDA MDR, EU vigilance)
MDR 83Post-market surveillance
8.2.4Internal audit
8.3Nonconforming product
8.5.2Corrective action (CAPA)
ISO 14971Risk management file
IEC 62304Software lifecycle
Part 11Electronic signatures
Supported out of the boxPartial, or needs an add-onNot supportedNot confirmed yet

Compare Formwork