Simplifying Medical Device Compliance.

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AI-powered eQMS for lean teams who prefer shipping code over PDFs. For EU MDR and FDA compliance.

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Formwork eQMS Screenshot (Requirements Management)

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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)

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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)

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Document Template

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Is Your Medical Device Safe? Understanding Biological Evaluation

Sebastian Skorka

updated 15 days ago

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IEC 82304: How Is It Different From The IEC 62304?

Anonymous

updated 6 months ago

We're just getting started with our medical device documentation, and we initially thought that we need to comply with the IEC 62304 regarding our software documentation. Now, someone mentioned the IE

Accepted answer

Don't worry about it. Auditors won't like me for saying this, but the 82304 doesn't contain much additional content on top of the 62304. Just comply w

4:43

Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates

Dr. Oliver Eidel

197 views • 8 months ago

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.

About us

Dr. Oliver Eidel

Founder & CEO

Germany

Ale Solano

Software Developer

Spain

Saurabh Sikchi

Software Developer

India

Sebastian Skorka

Consultant

Germany

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A complete step-by-step video course that walks you through medical-device compliance—from zero to audit-ready.

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Simplifying Medical Device Compliance.

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