---
description: Learn more about Formwork price, benefits, and disadvantages for businesses in Australia. Read reviews from verified users and discover similar tools that fit your business needs.
image: https://gdm-localsites-assets-gfprod.imgix.net/images/capterra/og_logo-e5a8c001ed0bd1bb922639230fcea71a.png?auto=format%2Cenhance%2Ccompress
title: Formwork Cost & Reviews - Capterra Australia 2026
---

Breadcrumb: [Home](/) > [Quality Management Systems](/directory/30099/quality-management/software) > [Formwork](/software/1109997/Formwork)

# Formwork

Canonical: https://www.capterra.com.au/software/1109997/Formwork

> Formwork is cloud-based software that helps medical device companies manage documents, requirements, risks, and compliance for audits.
> 
> Verdict: Rated \*\*\*\* by 0 users. Top-rated for **Overall Quality**.

-----

## Overview

### Who Uses Formwork?

Medical device manufacturers, from pre-revenue startups to mid-sized firms, needing an ISO 13485 QMS and technical documentation for EU MDR and US FDA. Used by founders, QA/RA managers, engineers.

## About the vendor

- **Company**: Formwork

## Commercial Context

- **Pricing model**: Flat Rate (Free version available)
- **Target Audience**: Self Employed, 2–10, 11–50, 51–200
- **Deployment & Platforms**: Cloud, SaaS, Web-based
- **Supported Languages**: English
- **Available Countries**: Canada, France, Germany, United States

## Features

- Audit Management
- Change Management
- Compliance Management
- Corrective and Preventive Actions (CAPA)
- Document Coding & Control
- Risk Management
- Training Management

## Integrations (1 total)

- Google Drive

## Support Options

- Email/Help Desk
- FAQs/Forum
- Knowledge Base
- Chat

## Category

- [Quality Management Systems](https://www.capterra.com.au/directory/30099/quality-management/software)

## Alternatives

1. [Qualio](https://www.capterra.com.au/software/134050/quality-management-software) — 4.6/5 (138 reviews)
2. [HSI Donesafe](https://www.capterra.com.au/software/141558/donesafe) — 4.8/5 (96 reviews)
3. [myosh Safety Management Software](https://www.capterra.com.au/software/138049/myosh-safety-management-software) — 4.4/5 (5 reviews)
4. [QT9 QMS](https://www.capterra.com.au/software/97557/qt9-quality-management) — 4.8/5 (124 reviews)
5. [Momentum QMS](https://www.capterra.com.au/software/158208/momentum-qms) — 4.8/5 (26 reviews)

## Links

- [View on Capterra](https://www.capterra.com.au/software/1109997/Formwork)

## This page is available in the following languages

| Locale | URL |
| en | <https://www.capterra.com/p/10054533/Formwork/> |
| en-AE | <https://www.capterra.ae/software/1109997/Formwork> |
| en-AU | <https://www.capterra.com.au/software/1109997/Formwork> |
| en-CA | <https://www.capterra.ca/software/1109997/Formwork> |
| en-GB | <https://www.capterra.co.uk/software/1109997/Formwork> |
| en-IE | <https://www.capterra.ie/software/1109997/Formwork> |
| en-IL | <https://www.capterra.co.il/software/1109997/Formwork> |
| en-IN | <https://www.capterra.in/software/1109997/Formwork> |
| en-NZ | <https://www.capterra.co.nz/software/1109997/Formwork> |
| en-SG | <https://www.capterra.com.sg/software/1109997/Formwork> |
| en-ZA | <https://www.capterra.co.za/software/1109997/Formwork> |

-----

## Structured Data

<script type="application/ld+json">
  {"@context":"https://schema.org","@graph":[{"name":"Capterra Australia","address":{"@type":"PostalAddress","addressLocality":"Sydney","addressRegion":"NSW","postalCode":"2060","streetAddress":"Level 18 40 Mount Street North Sydney NSW 2060 Australia"},"description":"Capterra Australia helps millions of people find the best business software with user reviews, ratings and price comparisons.","email":"info@capterra.com.au","url":"https://www.capterra.com.au/","logo":"https://dm-localsites-assets-prod.imgix.net/images/capterra/logo-a9b3b18653bd44e574e5108c22ab4d3c.svg","@id":"https://www.capterra.com.au/#organization","@type":"Organization","parentOrganization":"G2.com, Inc.","sameAs":["https://twitter.com/Capterra","https://www.linkedin.com/company/capterra/","https://www.youtube.com/channel/UCjRCDmEibpHwyX3m2b3y80w"]},{"name":"Formwork","description":"Formwork is a cloud-based quality management system for medical device companies preparing for regulatory audits. It centralizes compliance functions, managing quality documentation, technical specs, and risk assessments in one platform. Built on ISO 13485, IEC 62304, ISO 14971, and IEC 62366 standards, it supports EU MDR, FDA, and Health Canada frameworks for software and hardware devices. The system features document control with FDA 21 CFR Part 11 e-signatures and traced links connecting requirements, risks, and tests. An ISO 14971-compliant risk matrix tracks severity and probability pre- and post-mitigation. AI tools pre-fill documents to reduce setup time, while a sanity check identifies gaps before audits. Data exports are available in PDF, Markdown, and Excel. Operating on secure cloud servers in France and Germany, Formwork integrates with AI agents via its MCP server to automate tasks like CAPA drafting and risk linking.","image":"https://gdm-catalog-fmapi-prod.imgix.net/ProductScreenshot/e96a242c-6dd7-46bf-ade2-c144281bec92.jpeg","url":"https://www.capterra.com.au/software/1109997/Formwork","@id":"https://www.capterra.com.au/software/1109997/Formwork#software","@type":"SoftwareApplication","applicationCategory":"BusinessApplication","publisher":{"@id":"https://www.capterra.com.au/#organization"},"operatingSystem":"Cloud"},{"@id":"https://www.capterra.com.au/software/1109997/Formwork#faqs","@type":"FAQPage","mainEntity":[{"name":"What Is Formwork?","@type":"Question","acceptedAnswer":{"text":"Formwork is a cloud-based quality management system for medical device companies preparing for regulatory audits. It centralizes compliance functions, managing quality documentation, technical specs, and risk assessments in one platform. Built on ISO 13485, IEC 62304, ISO 14971, and IEC 62366 standards, it supports EU MDR, FDA, and Health Canada frameworks for software and hardware devices. The system features document control with FDA 21 CFR Part 11 e-signatures and traced links connecting requirements, risks, and tests. An ISO 14971-compliant risk matrix tracks severity and probability pre- and post-mitigation. AI tools pre-fill documents to reduce setup time, while a sanity check identifies gaps before audits. Data exports are available in PDF, Markdown, and Excel. Operating on secure cloud servers in France and Germany, Formwork integrates with AI agents via its MCP server to automate tasks like CAPA drafting and risk linking.","@type":"Answer"}},{"name":"Who Uses Formwork?","@type":"Question","acceptedAnswer":{"text":"Medical device manufacturers, from pre-revenue startups to mid-sized firms, needing an ISO 13485 QMS and technical documentation for EU MDR and US FDA. Used by founders, QA/RA managers, engineers.","@type":"Answer"}}]},{"@id":"https://www.capterra.com.au/software/1109997/Formwork#breadcrumblist","@type":"BreadcrumbList","itemListElement":[{"name":"Home","position":1,"item":"/","@type":"ListItem"},{"name":"Quality Management Systems","position":2,"item":"/directory/30099/quality-management/software","@type":"ListItem"},{"name":"Formwork","position":3,"item":"/software/1109997/Formwork","@type":"ListItem"}]}]}
</script>
