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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.

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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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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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Dr. Oliver Eidel

SimplerQMS Pricing: Starts At $1,200

Dr. Oliver Eidel
updated 10 days ago
A

How should changes to a QMS unrelated to the product be tracked under MDR?

Anonymous • 1 comment
about 18 hours ago
During a recent MDR audit, a minor non-conformity was issued because changes to our quality management system (QMS) that are not related to the product (such as changes in company leadership or new lo
Dr. Oliver Eidel

Accepted answer

In my case, I don't have a separate SOP for this type of change, but I mention it in the management SOP and keep a record for tracking process changes

4:43
Dr. Oliver Eidel

Medical Device Technical Documentation In 5 Minutes: Formwork Product Templates

Dr. Oliver Eidel

197 views • 9 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

Dr. Oliver Eidel

Founder & CEO

Germany
Ale Solano

Ale Solano

Software Developer

Spain
Saurabh Sikchi

Saurabh Sikchi

Software Developer

India

Sebastian Skorka

Consultant

Germany

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