Build safer products, faster.
AI-native medtech compliance that keeps up.
Integrate all of your data sources into a single platform. A living record of your |

Focus on innovation, not documentation.
Spend more time building. Infera means safer, smarter, more impactful devices in the hands of those who need them.
Deploy quickly & confidently with every team in a single, intelligent platform.
Faster releases
Free quality & engineering time to drive what matters most.
More capacity
Evidence & traceability available in an instant for safer, smarter devices.
Improved audits
Turn any document into traceable evidence
Built for every stage of your journey
From startups to established enterprises, Infera adapts to your compliance needs
Early Stage Startups
Go Live in Hours, Not Months. Start quickly with pre-built, FDA ready templates and a zero friction setup.
Growth Companies
Don’t sacrifice speed for safety. When product complexity climbs, our native platform ensures your compliance scales seamlessly with every team.
Enterprise Teams
Control complexity at global scale with a platform that delivers centralized management for complex product portfolios and evolving international regulatory landscapes.
Your favorite tools, ready to go.
Integrate with the technologies and platforms you already use.

Want to learn more?
See how we make compliance easy.
ISO 13485 · ISO 14971 · IEC 62304