top of page
Coauthor background.png
CoAuthor logo options Coauthor_logo_white horizontal large.png

A compliance assistant purpose built for SaMD

Gradient background.jpg

Describe your software development process using our questionnaire.

Step 1
Describe.jpg

Coauthor generates  IEC 62304 and ISO 14971 compliant documentation and ISO 13485 design and development documents for your QMS.

Step 2
Generate.jpg

Start coding while Coauthor monitors the software development tools,  highlights compliance issues and blocks non-compliant changes.

Step 3
Build.jpg

Get started in minutes, not months.

The Pain

Drafting and maintaining compliance documentation is a time-consuming drain on resources, especially for smaller teams and startups. It diverts focus from core development, slows innovation, and can lead to costly delays in getting your product to market.

Preparing for regulatory audits or submissions doesn’t have to be a burden.

Let Coauthor streamline and automate the process, so you can stay focused on what matters most.

Features

Streamline your compliance with Coauthor

SDLC Compliance Made Simple

Let Coauthor generate your IEC 62304 and ISO 14971 compliant documentation and ISO 13485 design and development documents for your QMS. Review, approve, start coding.

Assistant.jpg

Increase Developer Productivity

Use familiar tools and processes so developers can focus on writing code and generate compliance evidence as a by-product of their work. Engaging developers can lower costs by 30%.

Continuous Compliance.jpg

Continuous compliance

No expensive surprises when preparing for regulatory submission. Coauthor monitors the software development tools and highlights compliance issues as they occur. It will even block non-compliant changes.

Productivity.jpg
Built by Hindsight White.png

A software company with over 10 years of experience creating software development tools for MedTech, banks and e-commerce companies.

Purpose built for SaMD
From code to compliance - faster, smarter, together.
bottom of page