Kickstart your compliance

Setup compliant development processes for SaMD in minutes, not months.

Coauthor is in preview only. Sign up for early access.

SDLC Compliance without consultants

Describe your software development process to generate IEC 62304 and ISO 14971 compliant documentation and ISO 13485 design and development documents for your QMS. Review it, approve it and start coding.

Continuous Compliance

No expensive surprises when preparing a regulatory submission. Coauthor monitors the software development tools and highlights compliance issues as they occur, it can even block non-compliant changes.

Increase Developer productivity

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

built by

Hindsight Software

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

Optimised for SaMD

Your compliance assistant

Describe your software development process to generate IEC 62304 and ISO 14971 compliant QMS documentation along with automatic process enforcement, so QA/RA can focus on where they are needed.

Continuous Compliance.
Developers use their favourite code platform while coauthor monitors and highlights compliance issues as they occur and avoid regulatory debt.
Pull Request checks.
Enforce checks for evidence or required documents for your technical file on every software change. Never allow compliance to lag behind development.
Traceabililty matrix.
Generates a traceability matrix between requirements, risks, defects and verification tests. It will also report on missing links as changes occur.
Smart SOUP check.
Identifies when SOUP is added to your software and highlights when the required analysis is missing.
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A single development platform

GitHub for medical device development

Brings IEC 62034 and ISO 14971 required capabilities to GitHub and enables developer documentation authoring following the popular Docs-as-Code model.

Optimised for SaMD.
IEC 62304, ISO 14971 and ISO 13485 design and development processes streamlined for software development only, so you get to market faster.
Requirements Management.
Uses Specification-by-Example, BDD and GitHub Issues for requirements management and traceability
Risk Management.
Brings a straightforward a approach to ISO 14971 risk management and threat modelling for cybersecurity.
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Always audit ready

Automatic evidence capture

From code reviews to tests results, evidence is automatically captured from GitHub or your CI/CD Pipeline and published to your technical file ready for audit.

CD pipeline upload.
Evidence can be automatically uploaded from the build pipeline with full provenance and without API keys.
Test results for V&V.
Fully supports Cucumber, including screenshots and log files, for integration and system testing as software verification evidence.
SBOM.
Software Bill of Materials (SBOM) is an essential part of cybersecurity. Coauthor full supports recording CycloneDX SBOMs from software builds.
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