One platform. Full compliance.
Everything you need for compliant eIFU distribution, built by regulatory experts
Dedicated website for your eIFU
Our platform is EU/FDA regulation compliant and can be configured to suit your needs. Distinct groups of documents can be made available for different countries.
Multilingual Freephone service
Regulations require that paper copies of your documents can be provided upon request. Our worldwide call center is available 24/7 and takes the burden out of your hands.
Implementation support and regulatory acceptance
Integration and validation of your processes is in IFUcare's DNA. We ensure the regulatory acceptance of your eIFU solution with no hiccups.
Access control
Manage who sees what across your product documentation. Define roles, segment audiences, and ensure the right content reaches the right stakeholders — whether HCPs, patients, or distributors.
Restricted access
Need to share confidential documentation with specific users? Our platform lets you create personal access accounts and controlled document areas for non-public content.
Subscription module
As a manufacturer, you are required to notify customers who have previously downloaded an IFU on your website in the event of an update. Our platform includes an automated system to handle these notifications. No more manual interactions required!
One platform. Full compliance.
Everything You Need, Built In
Document Management
Upload, version, and archive IFUs, certificates, SDS, and quality documents with full audit traceability.
Country-Specific Availability
Control which documents are available in which countries. Configure distinct groups of IFUs per market to meet local regulatory requirements.
Multilingual and Global
60+ languages, all countries supported.
Intelligent Search
Find documents by product name, model number, UDI, language, country, or revision with smart filtering.
Audit Logging
Comprehensive audit trails for all actions, exportable reports for regulatory inspections.
Analytics & Reporting
Track downloads, search patterns, geographic usage, and system availability with detailed dashboards.
PLM/DMS Integration
Built API-first for seamless integration with your existing PLM, DMS, and enterprise systems.
Third-Party Penetration Testing
Our platform undergoes regular independent penetration testing to proactively identify and resolve vulnerabilities.
GDPR Compliance
Full compliance with EU data protection regulations. Personal data is processed lawfully, stored securely, and handled transparently.
Industry Solutions
Tailored for Your Industry
Whether you're a startup or global enterprise, IFUcare scales to meet your regulatory documentation needs.
Class I-III Device Manufacturers
Comprehensive IFU hosting for surgical instruments, implants, diagnostic equipment, and patient monitoring systems.
IVD Product Portfolio
Manage complex documentation for reagents, analyzers, and point-of-care testing systems across global markets.
Research & Laboratory Equipment
Technical documentation for research instruments, laboratory consumables, and scientific equipment.
Multi-Brand Portfolios
Centralized management for large organizations with multiple product lines, brands, and global subsidiaries.
See the platform in action
Schedule a personalized demo to see how IFUcare can streamline your eIFU distribution.