Automate eIFU compliance and focus on patient safety
Compliance, simplified for regulated medical devices.
eIFUApp helps Regulatory, QA/RA, and Operations teams publish, control, and distribute IFUs with confidence across EU MDR/IVDR and FDA requirements.
Built for regulated medical devices
Clear company identity, legal coverage, and compliance positioning that builds trust with RA, QA/RA, and Ops.
EU MDR/IVDR and FDA aligned
Support controlled release, versioning, and multilingual access across regulated markets.
Demo flow that qualifies fast
Capture role, market, and timeline so sales can prioritize high intent teams.
Solutions tailored to how teams buy
Dedicated pages for Regulatory Affairs, QA/RA, and Operations show how eIFUApp fits each workflow.
Regulatory Affairs (EU + US)
Cross-market eIFU governance for RA leaders managing EU and US compliance.
View Regulatory Affairs →QA/RA Workflow
Controlled updates, revision visibility, and audit ready workflows.
View QA/RA Workflow →Medical Device Operations
Reliable multilingual IFU delivery for global operations teams.
View Operations →What slows down your eIFU compliance?
eIFUApp reduces manual work, improves audit readiness, and keeps instructions current across markets.
Never worry about falling behind regulations again
Automate your eIFU management and stay compliant effortlessly with global standards, reducing the risk of costly fines or recalls.
Ensure your devices always have the latest instructions
Keep your patients safe with accurate, up-to-date eIFUs that are always accessible and easy to manage.
Free your team from manual processes
Reduce time spent on manual updates and document management, allowing your team to focus on innovation and growth.
Build trust with seamless compliance
When compliance is easy, your customers and partners see you as reliable and trustworthy, boosting your brand’s reputation.
Get the best compliance solution without breaking the bank
eIFUApp offers all the compliance tools you need at an affordable price, giving you premium service without the premium cost.
Stay ahead with automatic regulatory updates
No more chasing after the latest compliance requirements—eIFUApp automatically keeps your system up-to-date, so you can rest easy.