We help you ensure your medical device labeling complies with global regulations like the EU MDR, FDA, and others. MakroCare provides both IFU software and the associated shipping/mailing services, so you no longer have to rely on multiple vendors.

eIFU Services:

  • 24×7 Service Desk with ISO 20000 Policies: We maintain round-the-clock support and adhere to ISO 20000 standards, ensuring that our Service Level Agreement (SLA) is provided upfront to manufacturers. Periodic reports are shared to keep you updated on performance and compliance.
  • Timely Delivery of Printed IFUs: If users request a printed IFU, we ensure it is delivered within a maximum of 7 calendar days. We offer flexible options, including using our courier/shipping services or billing to your preferred vendor. Alternatively, requests can be forwarded to the manufacturer for internal fulfillment.
  • Compliant with EU MDR: Our eIFU services fully comply with the European Medical Device Regulation (MDR), keeping your product on the market without disruptions.
  • Seamless Transition: We assist in converting traditional IFUs into electronic formats, making it easier for your users to access information.
  • Enhanced User Experience: eIFUs offer better accessibility and multilingual support, enhancing the overall user experience.

Key Features of eIFU Software:

  • Complete Regulatory Compliance: Our eIFU software is fully compliant with the EU MDR electronic IFU requirements, ensuring that all your documentation remains compliant with the latest regulations.
  • User-Friendly Interface: Software is designed for ease of use, allowing your team to manage IFUs with minimal training.
  • Real-Time Updates: With our software, you can instantly update IFUs to reflect changes in regulations or product specifications, keeping you ahead of compliance challenges.
  • Multilingual Support: Software offers support for multiple languages, ensuring your IFUs are accessible globally.

Admin Access

  • MDR (EU 2021/2226), FDA and other regulations Compliant
  • Role & Permission Driven
  • Multi-language, Multi-versions linked by Products and Document versions
  • Enterprise version option with workflows, connect to your PLM & EDMS, custom branding and other premium features
  • 21 CFR Part 11, GAMP compliant and validated
  • Security measures and Privacy Policy are in compliance with GDPR

Your Benefits:

  • One Vendor, Full Solution: We provide both the service and the software, reducing the need for multiple partners and ensuring seamless management of your eIFUs.
  • Streamlined Process: From eIFU creation to compliance, our software enables efficient workflows, saving your team time and effort.
  • Enhanced Accessibility and Compliance: Our solution ensures that your eIFUs are available on multiple devices and accessible to users anywhere, while meeting stringent global regulatory standards.

For more information about our combined eIFU services and software, or to discuss how we can tailor a solution to your needs, contact MakroCare today.

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