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Purpose built for SaMD

Kickstart Your Compliance

Setup compliant development processes 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.

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Describe your software development process using our questionnaire.

Step 1
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Coauthor generates  IEC 62304 and ISO 14971 compliant documentation and ISO 13485 design and development documents for your QMS.

Step 2
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Start coding while Coauthor monitors the software development tools,  highlights compliance issues and blocks non-compliant changes.

Step 3
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Compliance doesn't need to be complicated.
Get started in minutes.

Features

Streamline your compliance with Coauthor

SDLC Compliance Made Simple

Let Coauthor generate your IEC 62304 and ISO 149071 compliant documentation and ISO 13485 design and development documents for you QMS. Review, approve, start coding.

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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.

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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%.

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

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