IFUcare — Electronic IFU Solution
Electronic IFU Solution for Medical Devices & IVD
IFUcare offers a seamless electronic IFU service for medical device and IVD manufacturers, empowering you to leave paper IFUs behind and transition to compliant, cost-effective electronic labeling.
Electronic IFU Solution for Medical Devices & IVD
Does your organization struggle with the challenges of paper-based Instructions for Use (IFU)? From high printing and logistics costs to complex compliance requirements, traditional IFUs can be a costly and time-consuming hurdle for in vitro diagnostics (IVD) and medical device manufacturers.
IFUcare understands your need for a more efficient, cost-effective, and compliant solution. That's why we offer a seamless electronic IFU service, empowering you to leave paper IFUs behind and transition to electronic labeling.
IFUcare helps manufacturers to distribute their technical documentation via a digital platform. We offer a single supplier solution, developed by regulatory experts with a focus on compliance and risk management.
With user-friendly navigation and robust features, IFUcare enables you to reduce costs, ensure compliance, and deliver a superior user experience. Our customizable, multilingual interface ensures accessibility for global users while meeting strict regulatory standards.
Why choose IFUcare?
Save paper & costs
Eliminate high printing, packaging, and logistics costs by transitioning to an electronic IFU service.
Simplify your process
Replace complex paper-based processes with a streamlined online platform that saves time and effort.
Differentiate your CX
Make documents easily retrievable and version-controlled, improving the experience for your clients.
Reduce risk
Reduce liability and product recall likelihood. Our solution is well-known to notified bodies, facilitating acceptance of your eIFU.
Comply with regulations
Meet EU, FDA, and other regulatory requirements with a solution purpose-built for compliance in regulated industries.
What our clients say
"Qarad has been very helpful in our recent transition from paper to electronic Instructions For Use. They offer a very professional eIFU service and platform. Changing to eIFU doesn't only save us costs but it's also very efficient. And of course it is good for the environment. Every company should basically be doing this. Apart from being very client focused and flexible, the Qarad team has excellent and up to date regulatory knowledge."
Peter Kievit
General Manager, White Implants
Why QbD Group
Your trusted partner
We have been a pioneer in electronic IFU services since 2008, addressing regulatory risks with a single-vendor solution developed by regulatory experts focused on compliance and risk management. Our eIFU services meet EU, FDA, and national requirements, ensuring your regulatory assurance. Key benefits include:
Regulatory expertise
Developed by regulatory experts with a focus on compliance and risk management.
EU & FDA compliant
Fully compliant with EU and FDA regulations (MEDDEV 2.14/3 for IVD and Commission Regulation (EU) No. 207/2012 on MD).
Full traceability
Logs of all user and administrator actions (21CFR11 compliant).
Familiar concept to notified bodies
ISO13485 and ISO27001 certified supplier. Software development according to IEC80002.
Multilingual support
Multilingual interface and worldwide multilingual support.
Time-efficient implementation
Smooth, time-efficient implementation process.
Configurable solution
Fully configurable user interface for an off-the-shelf solution.
Let's talk Software
From system validation to digital transformation, our software experts are ready to support your journey.