Simplifying Medical Device Compliance.

Open templates, open pricing, open playbook.
AI-powered eQMS for lean teams who prefer shipping code over PDFs. For EU MDR and FDA compliance.

Formwork eQMS Screenshot (Requirements Management)
Formwork eQMS Screenshot (Risk Matrix)

On the market since over 5 years.
Passed EU MDR and FDA audits.
Thousands of companies.

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Go to market faster.
With Formwork.

Formwork replaces Google Drive, Jira and Sharepoint with a purpose-built, AI-powered eQMS. Finish your EU MDR or FDA documentation while still shipping product every week.

  • ISO 13485 & EU MDR ready out-of-the-box
  • Real-time completeness checks & PDF exports
  • Audit-proof e-signatures (FDA 21 CFR Part 11)
Formwork eQMS screenshot (Free OpenRegulatory EU MDR Template)

Free EU MDR Templates.

We're on a mission to make medical device compliance transparent, accessible and free.
One step towards that was publishing all our document templates for free, no strings attached.
Covering ISO 13485, IEC 62304, ISO 14971 and IEC 62366.
Download now as Word, PDF, Markdown or HTML files.

  • ISO 13485 & EU MDR ready out-of-the-box
  • Real-time completeness checks & PDF exports
  • Audit-proof e-signatures (FDA 21 CFR Part 11)

Wait.. who?

We're a group of people who strongly believe that Healthcare needs some fixing. Innovation is slow, incentives are misaligned, and the compliance industry in particular is rather shady.