Ship regulated software at the rate of development
Automatically generate FDA-ready documentation that integrates with your eQMS, so you can build great products faster.
Everything you need to streamline medical device documentation and accelerate your development cycle
AI generated Automated software of unknown provenance
Keep test documentation in sync with your code. No more manual updates or version mismatches.
Auto-generated system documentation that stays current with your codebase. Never outdated, always accurate.
Seamless workflow integration with your existing project management tools. One source of truth.
Intelligent compliance checking powered by AI. Catch issues before they become problems.
Want to see these features in action?
Watch Demo VideoWatch how Qualtate transforms medical device documentation workflows in just minutes
See how teams are saving hours every week on documentation
Reduction in documentation time
Faster compliance updates
Get started in minutes, not months. Three simple steps to transform your documentation workflow.
Connect your codebase through GitHub or other integrations. Our AI-powered engine analyzes your code, tracks dependencies, and generates compliant documentation automatically.
Seamlessly export compliant documentation to your existing quality management system. No migration needed, no data loss.
Focus on building great products while Qualtate handles the documentation. Stay audit-ready, always.
Join forward-thinking medical device companies already using Qualtate to streamline their documentation.
Qualtate is built from the ground up to be secure and compliant. We never train on your data. Your IP stays yours, always.
Bank-level encryption and security infrastructure to protect your sensitive medical device data.
Built with HIPAA and SOC 2 compliance in mind. Ready for the most stringent regulatory requirements.
We never access or train on your proprietary data. Your IP stays yours, always.